TABLE 2.
Evidence | Gaps in Knowledge | |||||
---|---|---|---|---|---|---|
Criteria | Definition | Evidence Summary | Score | Gaps | Priority | |
i | Proof of concept | Ability to distinguish between subjects | Distinguishes CAD, HF, TOD, CV pathology | 4 | Data: beyond East Asia | 1 |
ii | Prospective validation | Future CVD morbidity/mortality predictive ability | High vs. low baPWV: CVD morbidity (HR: 2.6-3.4, RR: 3.0), CVD mortality (HR: 1.2-2.6, RR: 5.4), all-cause mortality (HR: 1.8-2.5) | 4 | Data: beyond East Asia | 2 |
iii | Incremental value | Predictive information beyond standard risk markers | CV event prediction ↑ when added to ACC/AHA risk score (X2: 21 to 50), ABI (AUC: 0.72 to 0.83), CTTA (X2: 132 to 154), SPECT (X2: 24 to 27), FMD (AUC: 0.71 to 0.75), & hs-CRP (X2: 126 to 167) | 4 | Data: beyond East Asia & in general populations | 3 |
iv | Clinical utility | Ability to move patients from one risk category to another | CV events: IDI = 1.6%, NRI = 52%. | 3 | Limited data from prospective studies in independent populations | 3 |
v | Clinical outcomes | Impact of clinical management with biomarker on clinical outcomes | No data available | 1 | Clinical management: support for aiding treatment | 4 |
vi | Cost-effectiveness | Incremental costs vs incremental benefits (life expectancy and QoL) | No data available, though likely high considering clinical utility & low examination costs | 2 | Clinical management: impact on life expectancy & QoL | 2 |
vii | Ease of use | Simplicity of measurement procedures | Measurements automated following cuff placement | 3 | Implementation studies: best practices for implementing within clinical workflow | 5 |
viii | Methodological consensus | Uniformity of measurements in different clinical settings. | No known guidelines exist | 1 | Consensus statement: measurement conformity across clinics, facilitating comparison to reference values | 5 |
ix | Reference values | Availability of published reference or cut-off values | Reference values for Chinese populations | 2 | Data: beyond East Asia | 4 |
Median evidence score | 4 |
Evidence Score / Gaps Priority Likert scale: 1 = very low; 2 = low; 3 = medium, 4 = high, 5 = very high. Abbreviations: ACC/AHA, American College of Cardiology/American Heart Association; CAD, coronary artery disease; CV, cardiovascular; CVD, cardiovascular disease; FMD, flow-mediated dilation; HF, heart failure; hs-CRP, high-sensitivity C-reactive protein; HR, hazard ratio; IDI, integrated discrimination improvement; NRI, net reclassification index; OR, odds ratio; RR, relative risk; QoL, quality of life; SPECT, single-photon emission computed tomography; TOD, target organ damage; X2, global chi squared.