A literature review was performed in July 2020 to identify guidance for the preparation of patient-facing documents. An initial scope of the literature indicated that guidelines relevant to this review could not be located within traditional academic databases. In fact, most of the relevant guidelines were in the form of reports from national literacy agencies, health authorities and regulatory bodies and were available on the organizations’ websites. Therefore, all entries on a Google search were examined by a single researcher (EC), using the search terms ‘Guidelines’, ‘writing’ and ‘Information Leaflets’. Following this, all reference lists were also checked. This process was independently repeated by a second researcher (LOS). The results from the search were combined and summarized by noting each result on an Excel spreadsheet. A piece of literature was deemed relevant if it purported to provide guidance on the preparation of public-facing documents for adult laypersons – this was not restricted to the medical or research context. A piece of literature was excluded if it provided guidance on preparing document for children or those with diminished or limited capacity, or wasn’t available in English. Since the majority of the guidance identified was not supported by quantitative data, each relevant document was independently appraised by two researchers (EC and LOS) using the Johanna Briggs Institute Critical Appraisal Tool for Text and Opinion [22].
Compilation of recommendations
Guidance from each document which passed critical appraisal was extracted and tabulated. This data was synthesized and 44 recommendations were proposed from themes and findings that consistently recurred and were grouped into five categories by two researchers (EC and LOS) and reviewed by clarity and completeness by two additional researchers (RC and PD). These recommendations were circulated to the ECC participants prior to the ECC for their review.
Expert consensus conference meeting
Eight key stakeholders were invited and agreed to take part in the ECC, which comprised of the following:
-
Lay member of a Research Ethics Committee (REC)
-
Expert member of a REC
-
A patient advocate from the Irish Platform for Patient Organisations, Science and Industry
-
A plain English editor and trainer from the National Adult Literacy Agency
-
An experienced clinical research nurse
-
An experienced principal investigator
-
A senior academic researcher with experience in inclusive research
-
An experienced qualitative researcher
-
A hospital data protection officer
Efforts were made to ensure that the composition of the ECC members was balanced, including both laypersons and researchers and also persons from different operational perspectives. The lay and expert REC members and hospital data protection officer were invited from the affiliated hospital. The principal investigator, research nurse and researchers were invited from the affiliated research centre and university. The patient advocate and plain English editor/trainer were invited from their respective organisations, as listed above.
The ECC lasted for 2.5 h and took place via videoconferencing (using Zoom) in August 2020. The participants provided verbal consent to participate and for the session to be recorded. The ECC was facilitated by a Chairperson (RC), and a Discussant (LOS). The Chairperson presented each recommendation to the participants, led the discussion between the members and ensured equal representation from each participant. The Discussant presented the findings of the literature review, including the available evidence and rationale for each recommendation. During the ECC, alterations to the recommendations were proposed, and consensus was reached on each separate recommendation. For each recommendation, following discussion, a unanimous agreement was reached by the ECC participants.
Finalizing recommendations
The amended recommendations were compiled using the ECC recording to ensure no input was omitted. The amended recommendations were circulated to the ECC participants who indicated their approval or provided further amendments. The final recommendations were then circulated and all of the ECC participants provided their approval. All approvals were documented.
Ethical approval
This study was granted a low-risk ethical exemption by the University College Dublin Research Ethics Committee (REC) – Ref LS-E-20-94-OSullivan-Doran.
Patient and public involvement
Two laypersons (one patient advocate and one layperson who is a member of a REC) contributed to all aspects of this ECC. Wherever applicable, this study was reported in line with the GRIPP2 Long Checklist (see supplementary file).