Most trials provide patients with written information sheets as part of the consent process. This ensures that all patients receive the same minimum details , which can be supplemented by discussion. The patient can take written material home and the benefits and risks of the trial can be considered in a less stressful environment, perhaps with help from family or friends . Initially such information sheets and consent forms were designed primarily to protect patients from unfairness or exploitation. However, as patient autonomy has become increasingly important, the focus of such documentation has become to help patients make their own decisions about treatment and taking part in trials, based on clear and accurate information. To accommodate this, the information provided has changed from the straightforward disclosure of information to an approach aimed at improving the quality of a patients' understanding of the proposed trial and treatments involved . In order to fulfil this role, information leaflets must be written in clear language that is easily understandable by the majority of patients and should be changed if important new evidence comes to light.
However, a study of consent forms used at a leading oncology centre in the US revealed that most of the forms were too complex to be read by most patients and their families . Another study comparing the reading ability of a sample of patients attending three US clinics found that only 27 per cent had reading skills that would enable them to understand pamphlets produced by the American Cancer Society and by the National Cancer Institute . Other research found that although 80 per cent of participants claimed to have read the consent form only 60 per cent reported that they had understood it. Only half could name all their drugs and just 4 per cent could list all the main side-effects .
It is therefore vital that information sheets and leaflets are presented and targeted appropriately. These should be written in plain language and avoid the use of jargon or complicated terminology. Words with specialist meanings in the context of trials should be explained. For example, the men interviewed as part of the ClasP trial found the use of words with common meanings outside of clinical trials to be confusing. The word 'trial' itself, which is usually associated with something that is being tried out or a difficulty, and 'random' which normally means haphazard were cited as being particularly difficult . In the ECMO trial a number of the parents understood 'trial' to mean 'on a trial basis' suggesting assessment of acceptability to the healthcare system rather than measuring potential benefits and hazards.
'Why the hell have we got it on trial when it's been in the States ... why is the National Health playing around with this' 
Similarly, interpretation of'fulfil the entry criteria for the ECMO trial' was interpreted by some parents as meaning that their baby was likely to be accepted for ECMO. This work raises many questions, not only for neonatal trials, but for trials in general as to whether it is time to rethink some of the terminology that researchers use to discuss and describe clinical research. Perhaps it is time to redefine the language of trials, or failing that to ensure that it is explained thoroughly and understood by those participating in trials. Further research is needed to investigate how we might best communicate the rationale of trials and into ways of adequately explaining randomization using non-pejorative terms.
Providing the right level of information and achieving a balance between avoiding complex scientific language and being patronizing can be difficult. It is important to remember that average reading skills of the public are low, and that participants are not uniform in their skills, experiences or need for information. In the UK, given that the average reading age of the adult population is around nine years, the Plain English Campaign advocates that public information should be written in language that can be understood by a nine year old child. Very few patient information sheets are pitched at this level and indeed such a level would not be appropriate for all individuals. One approach might be to produce a range of participant information material targeted at different types of individual. For example, an MRC/EORTC trial of chemotherapy in osteosarcoma has three separate information sheets one for adults and adolescents, one for children and one for parents. Clearly each requires different types and levels of information. Similarly, those with recurrent disease may be more likely to understand technical language (as they have had time to learn the terminology) than those who have been newly diagnosed. Offering patients a choice of detailed or more straightforward information leaflets, or indeed both, may help doctors consider inviting more patients to take part in trials. Trialists must also be able to harness other methods of imparting information, for example using pictures in information sheets or providing patient information audio or video tapes.
Undoubtedly, providing more written material will mean more work for trialists and trial support staff. However, individual researchers need not attempt to reinvent the wheel with each new trial, as much of the general information required will be similar across trials. As discussed in Chapter 7, there are many sources of guidance, examples and templates available. Such sources are a valuable resource for those writing patient information material. Ideally, drafting of this material should be done in active collaboration with a patient support or advocate group, to ensure that it is appropriately written.
Was this article helpful?
When parents help their children learn to read, they help open the door to a new world. As a parent, you can begin an endless learning chain: You read to your children, they develop a love of stories and poems, they want to read on their own, they practice reading, and finally they read for their own information or pleasure. They become readers, and their world is forever expanded and enriched.