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PostPosted: Sun Apr 08, 2012 9:39 am 
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Complex cancer industry trial literature is too confusing for patients to understand
By J. D. Heyes
cancer, literature, confusing

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Have you ever read something so complex and confusing that it frustrated you to the point of distraction? Well, a new study has found that cancer trial literature causes that kind of frustration - and may be misleading to patients as well.

According to Prof. Mary Dixon-Woods, professor of Medical Sociology at the University of Leicester Department of Health Sciences in Great Britain, a number of cancer patients found information leaflets describing cancer trials too long, too incomprehensible and too intimidating.

"These information sheets are poorly aligned with patients' information needs and how they really make decisions about whether to join a cancer trial," said Dixon-Woods, lead author of the research http://www.eurekalert.org/pub_releases/2012-03/uol-cti032612.php, which was published in the international journal Sociology of Health and Illness.

"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," she said.

Creating confusion among patients

Her research, conducted as a collaboration with the Departments of Health Sciences and Cancer Studies at the University of Leicester, sought to find out why cancer trial sheets are so difficult to get right. Tracing 13 cancer trials, Dixon-Woods and her team examined information sheets from when they were first prepared by researchers leading the trials through the review and approval process by ethics panels.

In addition, Dixon-Woods' team interviewed 26 patients who took part in the trials and were provided the information sheets.

"We found that research ethics committees examine information sheets very carefully," said author Dr. Natalie Armstrong, Lecturer in Social Science Applied to Health. "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, however, is that the information sheets are too busy. They seek to accomplish too much and, in the process, wind up accomplishing nothing but creating confusion among patients.

"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," Armstrong said.

"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,'" she said.

Simplification equals understanding

Said one patient, "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."

But all is not bad, researchers said. There are things that can be done to improve the situation.

"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," Armstrong commented.

"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," she said.

British medical officials welcomed the study and especially its recommendations to simplify the information sheets while still providing adequate, accurate information to prospective patients, said Hugh Davies, ethics advisor for Britain's Health Research Authority (HRA), which helped fund the study.

"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," Davies said.

Sources for this article include:

http://www.eurekalert.org/pub_releases/2012-03/uol-cti032612.php

http://onlinelibrary.wiley.com/doi/10.1111/j.1467-9566.2012.01469.x/abstract

http://www2.le.ac.uk/offices/press/press-releases/2012/march/cancer-trial-information-leaflets-not-fit-for-purpose-new-study?searchterm=natalie%20armstrong%20cancer%20trial%20sheets

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PostPosted: Sun May 10, 2015 1:17 pm 
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