Tri-agency Guide on Financial Administration (Webpage)

See the section "Gifts, honoraria and incentives" for guidance from the Tri-Council Agency.

Recommendations for developing accessible patient information leaflets for clinical trials to address English language literacy as a barrier to research participation (Webpage)

Background: Low English language literacy is a common barrier to participation in clinical trials. Patient information leaflets (PILs) used in clinical trials are often lengthy, complex and have poor readability; this is a persistent and prevalent problem common to trials across the world. Simplifying the information provided in PILs can lead to improved understanding, comprehension and knowledge.

The aim of this project was to develop recommendations for developing accessible PILs for clinical trials through a literature review of published and grey literature and co-working with marginalised communities, patients, and health and social care charities.

Methods: A literature review of MEDLINE, Embase and online resources was conducted, and recommendations for developing accessible PILs were extracted from eligible published and grey literature. Grey literature which contained insights into more inclusive forms of communication was also identified and summarised. Meetings were held with two racially marginalised community groups, two groups involving autistic adults and/or adults with learning difficulties and a patient advisory group. Examples of accessible PILs were shared and discussions held about the content and format of the PILs and suggestions for changes/improvements. National Voices, a coalition of health and social care charities in England, held a national online workshop with charities and lived experience partners. Recommendations identified from the multiple sources were coded, collated and refined to develop an overarching framework of recommendations.

Results: The framework consists of 74 recommendations for developing accessible PILs for clinical trials. Recommendations cover the five topics of formatting, information presentation, writing style, content and accessibility.

Conclusions: This project has developed a comprehensive framework of recommendations to guide researchers in the development of accessible PILs for clinical trials. Findings from previous research and from co-working with marginalised communities, patients and health and social care charities were collated to ensure that a diverse range of voices and experiences informed the framework. These recommendations aim to support researchers to develop better study information to reduce English language literacy as a barrier to participation in clinical trials.

Using plain language to communicate with clinical trials participants: Comparison of readability calculators (Webpage)

It is important that patient-facing clinical trial information is easily understood by potential trial participants, active trial participants, family members, friends and carers. The readability of a document refers to its typographic and linguistic characteristics that allow the text to be read and comprehended and it is recommended that healthcare providers aim that all information disseminated to the lay public be at a suitable readability level. Whilst there are established readability calculators for literature, there is no standard for health information. Several readability calculators are available that aid in the analysis of a text, URL or website's readability, however, to date there has been no head-to-head comparison of these. Five readability calculators were compared, including four online realtime calculators, (i) Readable (www.readable.com), (ii) www.webfx.com, (iii) www.datayze.com and (iv) www.online-utility.org, as well as the PC-based analyzer Microsoft Word (Microsoft Corp., USA). Three categories of text information were analysed, including (i) childrens' fairy tales (n = 20) (ii) scientific reports (n = 20) from BBC News websites and (iii) scientific abstracts (n = 20). This study demonstrated that varying scores were obtained by using different readability calculators. Based on these data in combination with issues including availability and ease-of-use, we advocate the use of Readable or Microsoft Word software to aid in the preparation of patient-facing clinical trial information. Clinical trial networks should now consider the need for standardisation of readability calculators and provide guidance to stakeholders so that readability of materials may be improved in a standardised and uniform manner.