Validated devices listing – Principles and procedure
The STRIDE BP Validated Devices Lists include only devices adequately validated and approved by the STRIDE BP Advisory Board and therefore recommended for clinical use. The STRIDE BP Validated Devices Lists are developed using data from:
- validation studies published as full papers in peer-review PubMed journals,
- newly performed independent validation studies (complete reports signed by the principal investigator),
- data on new devices provided by manufacturers showing ‘equivalence’ with previously validated devices.
VALIDATION PROTOCOLS
Validation studies of blood pressure monitors performed using the following protocols are considered (https://www.ncbi.nlm.nih.gov/pubmed/30003697):
- AAMI Association for the Advancement of Medical Instrumentation
- BHS British Hypertension Society
- ESH-IP European Society of Hypertension International Protocol
- ISO International Organization for Standardization
- AAMI/ISO
- AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)
INTERNAL AND EXTERNAL REVIEW OF VALIDATION STUDIES
- For each validation study a ‘STRIDE BP Validation Study Checklist Report’ is developed, which is specific to the validation protocol (and version) and the study population, and verifies key methodological aspects and results (device type, population, sample size, selection criteria, pass/fail criteria, conclusion, etc).
- Two members of the STRIDE BP team independently prepare a ‘Validation Study Checklist Report’ for each study. Any disagreement between them is resolved by the STRIDE BP Executive Management Board and a final report is generated (see figure end of page).
- Each validation study paper and the accompanying ‘STRIDE BP Validation Study Checklist Report’ are reviewed independently by two members of the STRIDE BP Scientific Advisory Board. Any disagreement between them is resolved by the STRIDE BP Executive Management Board. Devices approved are posted to the STRIDE BP website (see figure end of page).
STRIDE BP CRITERIA FOR VALIDATION STUDY APPROVAL/ REJECTION
Criteria for validation study rejection
- Validation pass criteria not fulfilled or not reported.
- Smaller sample size.
- Violation in the procedure or sequence of test and reference device blood pressure measurements or the number of observers.
- Validation in pregnancy without data in women with hypertension and preeclampsia.
Protocol violations which are accepted
- Minor violation in age and/or gender criteria.
- Minor blood pressure distribution criteria violation.
- Blood pressure level criteria not reported but grossly visible in scatterplot.
- Minor cuff distribution criteria (if applicable).
STRIDE BP ‘VALIDATED’ AND ‘PREFERRED’ DEVICES
- Devices that successfully pass the above described procedure will be listed on the STRIDE BP website as ‘VALIDATED’ devices.
- Validated devices that fulfill the following requirements will be listed on the STRIDE BP website as ‘PREFERRED’ devices, suggesting that these are the most appropriate ones to use.
OFFICE MONITORS
HOME MONITORS
AMBULATORY MONITORS
EQUIVALENCE CRITERIA FOR NEW DEVICES COMPARED TO PREVIOUSLY VALIDATED ONES
- A new device can be included in the STRIDE BP Validated Devices Lists without requiring a new validation study when there is documentation that this is ‘Equivalent’ to another ‘Reference’ device which has a validation study approved by the STRIDE BP.
- For the Equivalence procedure the device manufacturer submits a ‘STRIDE BP Device Equivalence Checklist’ including information on the ‘Equivalent’ and the ‘Reference’ device and their differences, signed by the manufacturer CEO.
- Devices with differences in (i) signal sensor (transducer) and processing, (ii) blood pressure estimation algorithm, (iii) inflation or deflation system, or (iv) cuff characteristics, typically are not regarded as Equivalent.
- The ‘STRIDE BP Device Equivalence Checklists’ are subjected to Internal (2 Reviewers) and External Review (2 Advisory Board members) as described above for original validation studies (see figure end of page). Devices approved by the Advisory Board as ‘equivalent’ are posted to the STRIDE BP website.
STRIDE BP VALIDATED DEVICES LISTING PROCEDURE
- Published validation studies;
- Data of newly performed validation studies;
- Data on devices showing ‘equivalence’ with validated devices.
- AAMI (Association for the Advancement of Medical Instrumentation)
- BHS (British Hypertension Society)
- ESH-IP (European Society of Hypertension International Protocol)
- ISO (International Organization for Standardization)
- AAMI/ISO
- AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)
Validated blood pressure measuring devices that fulfill the requirements below are listed as ‘Preferred’ devices.
- Upper-arm cuff devices.
- At least one STRIDE BP approved successful validation study published within 10 years before the current year.
- Automated storage of multiple readings, or mobile phone or PC link connectivity enabling data transfer (only for home monitors).
New device/study data entry or New equivalence device data entry devices.
Independent review and checklist by 2 Reviewers
Final Internal Review Submission to Advisory Board
Independent review and approval by 2 Advisory Board members
Final External Review Publish on the STRIDE BP website