According to a new study from the University of Leicester that has been published in the international journal Sociology of Health and Illness, patient information leaflets for cancer trials miss the mark, with patients declaring they are far too long, incomprehensible, and even intimidating.
Study author, Professor Mary Dixon-Woods, Professor of Medical Sociology at the University of Leicester Department of Health Sciences reports:
“These information sheets are poorly aligned with patients’ information needs and how they really make decisions about whether to join a cancer trial. Some patients did find them very useful, but many others paid them little attention. They preferred to rely on discussions they had with their doctor to make up their minds.”
The authors set out to find out why it is so difficult for cancer trial information sheets to get it right, and decided to evaluate the proceedings of 13 cancer trials in collaboration with the (UK) Departments of Health Sciences and Cancer Studies at the University of Leicester (UK) by examining information sheets from the time they were prepared by the researchers leading the trials, through being reviewed and approved by research ethics committees. The authors recruited 26 patients for their study who took part in trials and were handed the information sheets.
Author Dr Natalie Armstrong, Lecturer in Social Science Applied to Health explained:
“We found that research ethics committee examine information sheets very carefully. They are genuinely keen to make sure that patients are not misled in any way and that the information sheets are easy to read. They very often ask researchers to make changes to make sure they are suitable. The problem is that information sheets are trying to do too many things.
They end up having many of the features of a legal contract. Patients often find them far too long and incomprehensible, and even intimidating. In fact, many patients believed that the information sheets weren’t really produced for their benefit at all, but were more about researchers and institutions ‘covering their backs'”.
According to one study participant:
“There was a lot of jargon that didn’t really necessarily need to be in there. I think that there was a lot of information that sort of baffled you.”
The authors conclude that the cancer trial information sheets can be improved.
Dr. Armstrong said:
“Rather than using standardized templates, it might be better to have a list of principles that could be used when writing information sheets. It could also be valuable to involve patients themselves in helping to write and review them.
But we also have to accept that patients may continue to make their decisions about taking part in trials based on trust in their doctor, no matter how well written the information sheets are. We need to find ways to support doctors when recruiting to trials.”
According to The Health Research Authority (HRA), the study offered new insights into the consent process and the role of the participant information sheet.
Hugh Davies, HRA Ethics Advisor remarked:
“The HRA recognizes the evident dissatisfaction around participant information sheets. It is currently rewriting guidance that will focus on key principles rather than proscriptive instruction. It will work with public, patients, researchers and others involved in regulation and governance of research to look at all aspects of seeking consent, beyond the written information provided. We will support our work with evidence and consensus (where it exists) from the fields of research, ethics and decision-making.”
Written by Petra Rattue