Patient information sheet

We discuss general issues relating to the use of patient information sheets in Chapter 2 (see Section 2.3.4), but discuss the main practical aspects of drafting them here.

♦ State the name of the trial, its purpose, design and duration, and who is conducting and sponsoring it. Indicate why the patient has been invited to take part. State the advantages and possible disadvantages of taking part, indicating whether participants or only future patients are likely to benefit. Describe the treatment regimens and the possible advantages and risks associated with each of them. For randomized trials, explain the randomization process and why it is needed. If a placebo is used, explain why this is necessary. Arrange for the patient information sheet to be translated into all the relevant languages.

♦ Indicate the standard treatment the patient would be likely to receive if not in the trial.

♦ Describe what the trial involves, including not only the treatment regimens but also the investigations required.

♦ Indicate how data are recorded, assuring patients that confidentiality will be preserved.

♦ Explain that there is no obligation to take part and indicate patients' right to withdraw at any time without giving reasons and without affecting their relationship with hospital staff or their treatment.

♦ State what, if any, expenses will be reimbursed. Payments made to patients should only be for expenses reasonably incurred and that would not be incurred outside the trial. Payments should never be such as to constitute an inducement to patients to participate against their better judgement.

♦ State what will happen if new information becomes available during the trial, and what happens when the study stops.

♦ State how they can obtain further help and advice should they require it, and the complaints and indemnity procedures.

♦ Use simple non-technical language and short sentences.

♦ Invite critical comments on the content, wording and comprehensibility of a draft sheet from an independent body such a cancer charity or patient advocacy group.

Standard definitions of randomization, double-blind trial, cross-over trial, and placebo are available; the UK MREC definitions provide a useful model (http://www.corec.org.uk/wordDocs/pis.doc).

In the UK, the Central Office for Research Ethics Committees advises splitting topics into a series of questions and answers on the patient information sheet, and gives examples of possible wordings. The question headings are shown in Box 7.8, and further information can be obtained from their web site (http:www.corec.org.uk).

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