With the rapid development of the field of interventional therapy of cardiac valve, the innovative researches of interventional therapy of cardiac valve products have become the focus of global research. At present, there is a serious shortage of interventional valvular medical devices on the market in China, and large-scale interventional valve products are undergoing early human trials or confirmatory clinical trials. The effective quality control of clinical trials is of great significance to ensure that clinical trial data can be used to support the marketing of device products. By analyzing the problems in clinical trials quality control of interventional valvular medical devices in our hospital, and combining the characteristics of device products and diseases, we explore the key points of quality control and provide reference for the implementation and completion of high-quality clinical trials.
Clarifying the burden of disease is of great significance for determining the focus of healthcare and optimizing the allocation of medical resources. However, differences in research methods and assumptions often affect the comparability of different research results, thus leading to difficulties in healthcare decision-making. Disability-adjusted life year (DALY) is the most commonly used indicator to measure the burden of disease, but the reporting quality of disease burden studies using the DALY metric is uneven. To standardize the reporting of such studies, international scholars developed and recently published the STROBOD statement in Population Health Metrics. Its checklist includes seven parts: title, abstract, introduction, methods, results, discussion, and open science, involving a total of 28 items. To assist domestic scholars in better understanding and applying this reporting standard, this article interprets each item with published examples, aiming to improve the overall quality of disease burden research and provide high-quality evidence references for public health decision-making.