Core Outcome Set (COS) is an important approach to address problems in which the outcomes are inconsistent, non-essential and reporting biased in clinical researches. In order to ensure the standardization of the COS development process, the Core Outcome Measures in Effectiveness Trials (COMET) has initiatively developed the Core Outcome Set-STAndards for Development (COS-STAD). The recommendation includes 11 minimum standards, involving 3 common key domains: the scope, the stakeholders, and the consensus process. The COS-STAD is used by COS developers for standardizing research design, determining the quality of the methodology to develop a COS. Based on the background and conditions of clinical practice and clinical trials in China, especially the characteristics of the development of Core Outcome Set of Traditional Chinese Medicine (TCM-COS), this paper interprets the recommendations of COS-STAD, providing a reference for the potential users of COS in China.
ObjectiveTo develop the questionnaire and test its reliability for investigating route, prevention, and control of SARS-CoV-2 infection in medical staffs.MethodsThis questionnaire was development based on the COVID-19 relevant guidelines, official documents issued by the National Health Committee of the People's Republic of China, and published studies. The development group performed repeated discussions and drafted the first questionnaire, then performed expert consultation and revised the draft according to their suggestions. Eventually, some frontline medical staffs were invited to carry out pre-test investigation of the questionnaire and test its reliability.ResultsThe first draft included 48 items; 18 experts were invited in the first round questionnaire and 10 experts in the second round questionnaire. The positive coefficient of experts in these two rounds was both greater than 75%, and the authority coefficient of experts' opinions was greater than 0.70. The variation coefficient of these items was between 0.00 and 0.35, the coordination coefficient of experts was 0.193 (P<0.05). The experts of above two rounds put forward 14 suggestions for text modification or adjustment options of some items; after the development group held repeatedly discussions, a total of 8 items were performed secondary consultation and finally reached consensus. The final questionnaire included two domains of questionnaire before and after confirmed diagnosis. The domain "before confirmed diagnosis" covered 4 sections and 29 items involving infectious cause, plan and knowledge of prevention and control, and psychological symptoms. The domain "after confirmed diagnosis" covered 5 sections and 21 items, included symptoms, treatment, and psychological status after diagnosis; impact on the surrounding environment and people, and awareness of protection after infection. The pre-test results showed that the total items were considerably numerous, some items were difficult to understand, some laboratory results and treatment conditions were ambiguous, etc. After modification and re-testing, the test-re-test reliability of each domain was between 0.74 and 0.93, and the overall re-test reliability of the questionnaire content was 0.82.ConclusionsThis research has developed a questionnaire for investigating infection process, prevention and control of SARS-CoV-2 infection in medical staff, and the items considered two domains prior to and after confirmed diagnosis. The reliability and practicability of the questionnaire are acceptable.
Objective To develop a novel transcatheter tricuspid valve replacement device and test its performance. MethodsThe transcatheter tricuspid valve stent consisted of double-layer self-expanding nitinol stent, biotissue-derived bovine pericardial leaflets, and PTFE woven. The delivery system, mainly consisting of a handle control unit and a delivery sheath, was sent to the correct position via right atrium or jugular vein. The sheath had a visualization feature, and the handle control unit could realize the functions of stable release and partial recovery of the interventional valve. In addition, this study performed animal survival experiments on the basis of in vitro experiments. A large-white pig was used as the experimental animal. Cardiopulmonary bypass was established through median thoracotomy, then the right atrium was opened, and the interventional valve was released under direct vision without cardiac arrest. Approximately 1 month after interventional valve implantation, the maneuverability and stability of the interventional tricuspid device were evaluated by autopsy. ResultsThrough the animal experiment, the interventional valve was successfully released, and the anchoring was satisfactory. Postoperative transthoracic echocardiography showed that the interventional valve opened and closed well, the flow rate of tricuspid valve was 0.6 m/s, and there was no obvious tricuspid regurgitation. One month after the operation, we dissected the large-white pig and found the interventional valve was not deformed or displaced, the leaflets were well aligned, and there was thrombus attachment in the groove between the inner and outer layers of the interventional valve. ConclusionAnimal experiment shows that the novel device can stably and firmly attach to the tricuspid annulus, with good anchoring effect, and effectively reduce paravalvular leakage.