In the near future, results from several large RCTs with hard endpoints will be available.
However, studies focusing on hard endpoints and comparing Diabetes Clinic attendance vs. no attendance are scant.
However, further rigorously designed randomized controlled trials are warranted to assess the effect of TCM on long-term hard endpoints in patients with cardiovascular disease.
Up to now, no randomized study has been conducted assessing the long-term effects of the Mediterranean diet on the "hard" endpoints of clinical cardiovascular events.
In this statistical analysis, a threshold z-value of 2 is generally accepted in most publications [5, 11 14], but this threshold was arbitrarily selected mainly because of lack of hard endpoints (ground truth) and small sample sizes.
[14], [15] We classified the type of primary endpoints as hard endpoints, intermediate endpoints and subjective endpoints.
However, randomised controlled trials powered on these hard endpoints need to be conducted to prove efficacy.
A comparison of hard endpoints like high-grade AV block would be more convincing.
Clinical outcomes in this study were limited to validated hard endpoints.
Invasive haemodynamic parameters are considered to represent hard endpoints, which are optimal for phase II trials.
The hard endpoints are clear and unequivocal, i.e. revision reconstruction and total knee replacement.
