Testing consent materials with readers before the trial uses them

A participant information sheet or consent form can be tested before a trial relies on it, to establish whether the people it is written for can find and understand what it says. The full test measures this with readers from the target group and revises the document until it passes. Patients and patient advocates can review the documents and the graphics in them. A simpler check asks one lay reader who is not familiar with the study to point out what they do not understand.

User testing

Clinical trial patient information sheets have been tested and improved with user testing. ¹ User testing judges a document by how it performs rather than by what it contains. ² Participants from the target group are interviewed one to one and use the document to answer questions about a set of key points. ² The target is that 90% find each point and 90% of those show they have understood it, and the document is revised and retested until no problems remain. ²

Testing alone does not improve the document, so it has to be combined with expertise in good writing and design. ² The testing identifies the points people struggled to find or understand, and these are remedied using research evidence and good practice in writing and design before the document is tested again. ²

Review by patients

Collaborating with patients and with doctors on the consent form is held to be very important, because in the end it should meet their needs and not be only a legal document that someone signs without really understanding its content. ³ Incorporating patient feedback in consent forms is important for improving participants' understanding. ⁴ Doing so supports best practice in patient-centred communication and shows the value of engaging patients in developing clinical trial materials. ⁴

Patient advocates are in the best position to assess the level of patient-facing clinical study documents, such as informed consent forms and safety updates. ⁵ In one spinal muscular atrophy development programme, for example, patient organisations reviewed the informed consent forms. ⁶

A graphic developed to improve potential participants' understanding of trial data privacy in the informed consent process was improved significantly after review by patient experts. ⁷ Thirty international patient experts gave feedback, through a pre-meeting survey and a face-to-face meeting, on the clarity of the information, the effectiveness of the visual elements and the overall layout of the graphic. ⁸ Their quantitative and qualitative feedback was summarised and used to inform updates to the graphic. ⁸ Its layout, text and imagery were then improved to make the information more accessible and easier to understand. ⁹ The revised graphic was tested again with the patient experts to make sure the changes led to better comprehension, and this second round of feedback indicated that the graphic had become more accessible. ⁹

Review by a lay reader

Asking a lay person who is not familiar with the study to read a draft and point out any parts they do not understand is always useful. ¹⁰ In the UK, a participant information sheet that follows the Health Research Authority's guidance should be tested on someone unconnected with the study. ¹¹ Together with following the guidance and proofreading the sheet, this testing minimises problems in obtaining a favourable opinion from the research ethics committee and ensures that participants fully understand what is being asked of them and can give truly informed consent. ¹¹