Writing patient information sheets
2014 Conference
Abstract: The Patient and Public Involvement (PPI) group within the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL) developed a patient information sheet template in 2009, to be used by trial teams within the unit. Two patient representatives from the National Cancer Research Institute Consumer Liaison Group were involved in the development of the template.
In 2013, the patient and public involvement (PPI) group reviewed the template and agreed that although the content met all the requirements criteria set out in the National Patient Safety Agency (NRES) guidance, the format was not patient friendly and a new format could make the information easier to read and improve the understanding of our research for potential patients. A new format was developed in partnership with the group’s patient representatives, Ben Cromarty and Richard Stephens, and two trials that are currently in development are now piloting this format. The layout, appearance and structure of the information sheets were revised for the new format and were based on tested materials by Knapp et al (1). A new template will be based on these examples once ethics approval has been obtained.
This workshop is about writing and setting out patient information sheets that are effective at presenting information to potential research participants, and to discuss good practice, share ideas and experiences.
The workshop will begin with a short exercise in pairs asking people to explain their research in plain English.
We will briefly outline the background to the development of the new format (see above).
We’ll ask people to share any examples of information sheets that they have seen that are really effective at displaying information or any that are poor, and encourage a whole group discussion about these.
We’ll ask people to look at the template and to discuss their views in small groups. We’ll then get people to work individually or in pairs to develop a patient information sheet, using our template. We will then give feedback on these drafts, and we’ll award a prize to the best draft.
The workshop is itself part of our process for developing our new format for patient information sheets, and we will offer the opportunity to workshop participants in any further development work, if they wish to be involved.
Reference
1. Knapp P, Raynor DK, Silcock J, Parkinson B. Can user testing of a clinical trial patient information sheet make it fit-for-purpose?-a randomized controlled trial. BMC medicine. 2011; 9: 89.
Authors
Cromarty ~ Ben
Ben Cromarty works with North Yorkshire AIDS Action charity and is a member of the UK-Community Advisory Board (UK-CAB) for HIV. He is the British HIV Association (BHIVA) Scientific and Education Sub-Committee Representative and a member of both the PIVOT (Protease Inhibitor monotherapy Versus Ongoing Triple-therapy in the long-term management of HIV infection) Trial Steering Committee and the Clinical Trials Unit at University College London (UCL) Patient and Public Involvement (PPI) Group.
View all articles by this authorMurphy ~ Claire
Claire Murphy is a trial manager at the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL). She is currently managing a new trial looking at aspirin in the treatment of cancer. As a member of the Unit’s patient and public invovlement (PPI) group, she is leading work towards improving the Unit’s patient information sheet template.
View all articles by this authorSouth ~ Annabelle
Annabelle South is the Research Impact Officer at the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL). She works to improve communication of the Unit's research and ensure it has maximum impact. Annabelle is an active memebr of the Unit's patient and public involvement (PPI) group, with current interest in improving the engagement of study participants.
View all articles by this authorStephens ~ Richard
Richard Stephens has patient experience of research having participated in nine clinical trials or other studies. He chairs National Cancer Research Institute (NCRI) Consumer Liaison Group (CLG) and National Institute for Health Research (NIHR) Cancer Patient and Public Involvement Steering Group (PPI SG), and is a PPI rep for NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC), Medical Research Council (MRC) Clinical Trials Unit (CTU) and Research for Patient Benefit (RfPB). He serves on two trial management groups (TMGs) and on several advisory boards, including Genomics England.
View all articles by this authorVale ~ Claire
Claire Vale is a researcher at the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL). As well as conducting and reporting systematic reviews, she also leads the Unit's patient and public involvement (PPI) group and has been involved in a number of activities relating to PPI through her work.
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