Monday, January 17

Haukeland with its own review: Only four patients were incorrectly included in the cancer study

Haukeland University Hospital has now come up with its own report on what went wrong with the Norwait cancer study. They find that only 4 out of 31 patients were incorrectly included. An earlier report has shown that 16 were incorrectly included.

Haukeland has reviewed the records of the 31 patients who participated in the cancer study Norwait.

Aftenposten has written in several articles about the Norwait cancer study for patients with rectal cancer. It was stopped over a year ago. Several patients at Haukeland experienced further growth of the tumor and spread to other organs.

But how many patients were actually mistakenly included in the cancer study? Two reports come with completely different numbers.

Haukeland Hospital has now itself reviewed the records of the 31 patients. The report states that four patients may have been included in the study on incorrect grounds. These four patients should have been referred for surgery.

The figure stands in stark contrast to the national review that a group of surgeons delivered in December. They were appointed by the steering committee for the study. Here it was determined that 16 of 31 patients should not have participated in the study at Haukeland.

Eight patients experienced further growth of the tumor and spread to other organs. Of these, seven were incorrectly included, according to the national report.

One of the patients was recently interviewed in Aftenposten. He spread the cancer to his lungs and lymph after participating in the study. The operation on the cancerous tumor in the rectum was postponed because the 65-year-old joined the “wait-and-see” scheme. Only a few weeks ago did he learn that he had been mistreated.

The 65-year-old has contracted cancer and incurable cancer after participating in the study at Haukeland.

Have a different interpretation

The Research and Development Department (R&D) at Haukeland has reviewed the patient records.

Ingrid Smith is section leader for Patient Safety at the R&D department.

She believes that the differences in figures for incorrectly included patients are due to different interpretations of the criteria for the study (research protocol).

– We have interpreted it so that pictures of the rectum are not mandatory, but will confirm findings made by other examinations. If these images are a necessary criterion for including patients, it is true that more than four patients may have been incorrectly included, she says.

She believes it must be up to the supervisory authorities to compare the findings in the two different reports, set against the research protocol.

But she adds that pictures of all the patients in the study should have been taken anyway. – It is a serious discrepancy that the research group in Helse Bergen has not done so, she says.

The explanation given for the missing pictures is that the equipment was not available.

Have not gone into the doctors’ assessments

The hospital’s review of how the research protocol has been followed is based solely on information documented in the patients’ medical records.

– We have not decided whether the doctors’ assessments were clinically correct or not, Smith emphasizes.

She points out that the national review was done by gastrosurgeons who themselves have contributed to the Norwait study and have specialist expertise.

– Our review was done by specialists to evaluate documentation in patient records against research protocols. However, they do not have clinical expertise in gastrosurgery. This may be the explanation for some of the differences in the two reports.

Left: This is what a tumor in the rectum looks like. It can be felt if the doctor examines with a finger. Right: This picture shows the «complete response»: The tumor is completely gone and the area has been replaced by a white, flat scar without wounds. Flexible endoscope is the only way to take good enough pictures of such tumors or “tumor sites”.

Aftenposten has asked for a comment from the two gastrosurgeons who performed the review at Haukeland in June, Arne Færden from Ahus and Stig Norderval from the University Hospital in northern Norway. Together with the leader of the group, Morten Tandberg Eriksen (OUS), they write in an e-mail:

“For us, it seems that the difference is due to the fact that Haukeland in its report has not assessed the content of the documentation that exists. In our report, we have made an independent assessment of the described findings. In our opinion, the description in more than half of the patients was not in accordance with the complete clinical response (that the tumor had completely gone back, ed. Note).

We have also described the significant lack of photo documentation as a significant breach of protocol. “

– Do not attempt to beautify

– Can their report appear as a defense of the way Haukeland has conducted the study, Ingrid Smith?

– Absolutely not! The report documents deviations upon deviations from the research protocol. This is not an attempt to paint a picture, she states.

Smith says Helse Bergen may have caused patients an extra burden by participating in the study. – Therefore, we take this matter very seriously. We must now do what we can to follow up on these patients. In the report, we describe specific measures we believe should be implemented so that something like this does not happen again.

– The new report does not take into account whether the follow-up of the patients was medically sound. Why not?

– The starting point for the report has been a research ethics issue. This case is now being followed up further by the Norwegian Board of Health. In order to obtain an assessment of whether the treatment of the patients has been medically justifiable, we have also reported the case to the State Administrator in Western Norway.

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