Chapter 1218 Let Go of the Inclusion Criteria!
On Saturday morning, more than a dozen people led by Chen Cang gathered in the discussion room.
Director of Cardiac Surgery Xu Ziming is reporting the situation.
"We analyzed the efficacy, safety and other indicators of the first-stage surgery patients, and the results showed..."
"The average operation time of our team is about 5 minutes less than the current mainstream operation, but if Mr. Chen performs the operation, it may save more time, but... this cannot be used for the results of our clinical analysis."
"From the perspective of efficacy analysis and safety, the efficacy is still the judgment of the surgical effect, and we have reached the level reported at the 2019 World Large Vessel Conference."
"In terms of safety... there are mainly two aspects, the first is mortality, and the second is complications. Because our inclusion criteria are relatively strict, we have not yet started the study of mortality, and the main focus is on complications. ."
"The complication rate is already lower than the 2019 figures because of our efforts in operating time."
After Xu Ziming's data came out, everyone at the scene couldn't help cheering!
After all, their efforts were not wasted.
This data means they are ready for clinical surgery.
They have reached the current national average.
Even Chen Cang was really happy in his heart.
He couldn't help but start clapping, sending applause to their team members.
Until now, Chen Cang has not had to do every operation by himself.
Instead, he was helping their team members, taking them with them to the surgery.
Because a person's ability is ultimately limited.
So far, among the first 12-person team, five or six people have been able to complete the operation, including Li Baoshan, Xu Ziming, He Zhiqian, Liu Quan and others.
They are the first backbone!
improve rapidly.
But what makes Chen Cang curious the most is Xu Aiqing. She is currently the hardest working and the fastest progressing member of the team.
For the sake of the child, Xu Aiqing is really working hard.
Everyone was happy and excited.
Their success means saving more patients.
but……
The end of the operation of the patients in the first stage immediately means the beginning of a new stage.
Xu Ziming said at this time: "Mr. Chen, how do you plan to carry out the second phase of the case."
The room was quiet now.
During the first phase, they followed strict requirements and inclusion criteria, and achieved remarkable results.
What about the second period?
How to develop?
After pondering for a moment, Chen Cang said lightly: "In the second phase, let go of the inclusion criteria and do a mortality study!"
As soon as these words came out, the surroundings became quiet.
Mortality study!
Everyone's heart could not help but shake.
Mortality research has always been an area that no discipline wants to touch.
The efficiency that everyone is talking about is actually not the real efficiency.
And how to incorporate the efficiency of the standard.
This is an inaccurate data.
However, the sample is really released, and the inclusion criteria are greatly relaxed, so that the real data is actually the case study.
In fact, life is more cruel than data.
This is the case with mortality studies, for example.
This is completely to let go of the inclusion criteria of cases to study mortality.
Thinking of this, everyone couldn't help but look at Chen Cang.
Is this...isn't it a bit sloppy?
After all, such a good foundation laid in the first issue... Isn't it... It's a pity to be buried!
Everyone thinks of this, and they feel a little distressed.
Because once the inclusion criteria are released now, if 100 cases are analyzed for efficacy and sequelae, it is obvious that compared with the data of the first phase, it will definitely decline.
Both safety and efficiency must be reduced!
This opening is a good hand, is it really going to be broken?
Everyone was apprehensive and uneasy.
Xu Ziming couldn't help but say, "Mr. Chen... Isn't it a pity!"
"With such a good result in our first phase, no matter who it is given to, we will definitely carry out follow-up research to further improve efficiency and safety, and reduce complications. In this way, our data..."
Chen Cang didn't change his face, and asked lightly, "What's the use of us asking for data? No matter how good the data is, it's useless!"
"When we set up the project to study, everyone's purpose should not only be to get a beautiful clinical data, right?"
"Our core purpose is still to save people!"
Everyone fell silent.
What Chen Cang said was right, but... he was still a little unwilling.
Everyone is doing it, and we can do it too!
After all... there is a difference between clinical trials and actual surgery.
We cannot exclude a patient because he did not meet the inclusion criteria and not be operated on.
In this case, our research is meaningless.
But……
Everyone just feels a little pity.
Think of An Zhen, think of Ruijin.
Their emergency center also wants to have a good special department, a top department that is well-known in the whole country and the world.
However, this is not a matter of a day or two after all.
Now the clinical research on the thoracoabdominal aortic replacement surgery of patients with Marfan is very researched. Once the results come out, it will obviously win the award!
But……
Chen Cang's whimsical operation made the entire team feel a little regretful.
To be honest, if Chen Cang didn't change his policy or direction, and he had done the surgery as it was, he would have won an award for his achievements!
Hey……
Everyone couldn't help but sigh.
"Mr. Chen, we... I still think we should improve the efficiency. After all, we have come so far. Now that the inclusion criteria are released all of a sudden, the mortality rate and the chance of complications will suddenly increase, and it is difficult for us to reduce it. These factors!" He Zhiqian also wanted to fight for it.
Chen Cang suddenly smiled: "Can't we let go of the inclusion criteria to talk about the treatment rate? Or can't we let go of the inclusion criteria to study the probability of complications? Moreover, it can also include mortality!"
"In this case, the ratio will be greatly reduced!" Xu Ziming couldn't help saying.
Chen Cang shook his head: "This data will be more real, it will be more applicable to ordinary patients, and it will be more helpful to the medical field."
"And, who's to say we're bound to drop these percentages?"
This sentence made everyone stunned!
It's definitely going down!
If the inclusion criteria are released, the risk factor of patients will be greatly increased. The most dangerous thing in Marfan syndrome is the sudden rupture of large blood vessels and death on the operating table.
However, what did Teacher Chen mean just now?
Is it...
Does Mr. Chen have a better way?