Published: 28-03-2017 09:33 | Updated: 28-03-2017 10:31

Karolinska University Hospital guidelines to prevent unproven methods

Karolinska universitetssjukhuset

Karolinska University Hospital has now drawn up guidelines to prevent unproven methods from being used, as in the case of Paolo Macchiarini’s trachea transplants. Such guidelines have not existed previously. Cooperation between the hospital and Karolinska Institutet was also one of the topics discussed during a seminar on the new guidelines.

The guidelines have been drawn up in collaboration with Ingemar Engström, expert member of the Swedish National Council on Medical Ethics. He commented on the grey area that is often spoken about between research and healthcare.

“I want to banish the term grey area because such a concept must not exist. On the other hand, there is a borderland, occasions when methods that have not been tested may be used. A strict regulatory framework is needed and one is now incorporated in the new guidelines.”

The background to the new guidelines is the criticism of the hospital made by external investigator Kjell Asplund in his report on ‘The Macchiarini Case’. The new guidelines are intended to ensure patient safety and provide support for colleagues and those responsible for the university’s activities. But they are also intended to contribute to the development of healthcare, said Nina Nelson Follin, Director of Quality and Patient Safety, Karolinska University Hospital, during the seminar on 17 March.

According to the guidelines, unproven methods may only be used when it is reasonable to assume that the patient’s suffering will be alleviated. Studies must have been made using an animal model that have shown a positive effect without excessive risk, which had not been done in the right way before Macchiarini’s trachea transplants.

When all the preconditions have been fulfilled, a plan for the treatment is to be submitted in writing to a committee of independent experts.

“An informed consent form containing complete and intelligible information to the patient must also be provided. This is demanding but must be allowed to take the time necessary,” said Nina Nelson Follin.

Division of responsibility may not be clear

Karin Dahlman-Wright, acting vice-chancellor at Karolinska Institutet, spoke about integration between universities and hospitals. Lack of clarity where division of responsibility is concerned was taken up in Kjell Asplund’s report.

“An understanding of each other’s activities and operations is needed and it is important that we send the same message. We must discuss responsibility and authority,” Karin Dahlman-Wright said.

She described how collaboration between the hospital and KI should be carried on.

“We must be very open, we must welcome discussions about science and ethics. No one must be able to hide behind excellence or status. Everyone must be able to have their say and no one is to feel that an opinion is stupid.”

Properly conducted conferences

Guidelines for multidisciplinary conferences were also presented at the seminar. The hospital has been criticised for the multidisciplinary conferences that were held for Macchiarini’s patients.

“The multidisciplinary conferences are the most important decision process for a patient. Many have taken for granted that people know what such a conference is but it is not just a matter of meeting each other,” said Harald Blegen, Head of Tema Cancer, who has worked on the guidelines.

The hospital has also reviewed and revised a number of medical concepts. The term vital indication is no longer to be used because it is too vague and allows scope for personal interpretation. At Karolinska University Hospital, vital indication has been used for situations where patients’ condition has been life-threatening in the long term, while other hospitals are normally referring to patients who may die within a few hours or days.

Text: Ann Patmalnieks

More about the new guidelines:
Karolinska University Hospital has adopted twelve rules for using unproven methods. There must be a living document that can be updated along the way. Unproven methods are defined as methods that can be used on a seriously ill patient when tried and tested treatments are lacking or have proven to be ineffective.
The guidelines for multidisciplinary conferences contain detailed requirements concerning method, division of responsibility and documentation. A specific point states that a responsible head is to ensure that participants understand the risks that groupthink entails. The guidelines are a proposal that may be revised before being adopted.
A multidisciplinary conference brings together specialists from different disciplines and professions to jointly recommend a treatment strategy.