Accessing the Clarity and Acceptability of Recruitment Materials for a Study on Thoracic Aortic Disease Surveillance

Overview

People who are invited to take part in health research are usually given written information, such as invitation letters, and information sheets. These documents are essential because they help people understand what the study involves and decide whether they want to take part. However, many studies have shown that research information is often too complex, too long, or written in technical language. This can make it difficult for people to fully understand the study and give informed consent. This study aims to assess how clear, accessible, and acceptable draft research documents are for a proposed future doctoral study related to thoracic aortic disease. Thoracic aortic disease is a long-term condition that requires regular monitoring, and people in surveillance programmes may be invited to take part in research. It is therefore important that study information is clear, sensitive, and easy to understand. In this study, staff and students from the University's School of Health Sciences will be asked to review draft recruitment materials. These materials include a study invitation, an information sheet, and interview guide. Participants will be asked to give feedback on how easy the documents are to read, whether the information is clear, whether the tone feels appropriate, and whether the amount of information feels reasonable. The study will also use a standard readability tool to assess whether the documents are written at a level suitable for the public. This research does not involve patients and is considered low risk. Its purpose is to improve research materials before they are used with patients, helping to support informed consent, reduce confusion, and improve ethical and inclusive research practice in future studies.

BACKGROUND AND RATIONALE: Recruitment materials such as information sheets, consent forms, and questionnaires help people decide whether they want to take part in research. These documents are important because they explain what the study involves and help people make an informed choice. If the information is too technical, too long, or given at the wrong time, people may feel confused, anxious, or decide not to take part. People with thoracic aortic disease (TAD) attend regular hospital appointments for monitoring and imaging. During these visits, they may be invited to take part in research studies. These moments can be stressful, and patients may find it difficult to process complex research information. This study will explore how recruitment materials are written, when they are given to patients, and how patients understand them in the context of thoracic aortic disease surveillance. The aim is to identify ways to make research information clearer, more appropriate, and easier to understand, so that people can make informed decisions about participation. The findings will be used to improve recruitment materials and strategies for a future doctoral research study. This will help support ethical recruitment, reduce participant burden, and promote fair and inclusive participation in thoracic aortic disease research. The study seeks to answer the following research questions: * Are the recruitment research materials (including the study invitation, participant information sheet, and interview topic guide) clear and understandable? * Are the materials written at an appropriate reading level for the public? * How do potential participants perceive the tone, emotional impact, and acceptability of the materials? * Do the materials clearly explain what participation would involve, including time commitment and expectations? * What improvements can be made to enhance clarity, accessibility, and acceptability prior to use in future research? STUDY AIMS Main Aim To assess the clarity, accessibility, and acceptability of proposed Recruitment research materials developed for future doctoral study. Objectives * To evaluate whether Recruitment materials are clear and understandable. * To assess the readability of materials using recognised readability tools. * To explore perceptions of emotional tone and information burden. * To examine the acceptability of proposed research procedures and participant burden * To refine materials in preparation for further doctoral research. STUDY DESIGN Methodology: This study uses a qualitative feasibility design to explore whether and how recruitment materials could be improved before using in a future doctoral research project. Qualitative methods are appropriate to examine perceptions of clarity, tone, accessibility, and perceived burden, which cannot be fully captured using quantitative measures. The study aims to generate practical insights rather than statistically generalisable findings, consistent with feasibility research principles. Sampling Strategy: Departmental mailing lists and internal communication will be used in a convenience sampling strategy. Recruitment materials will be widely distributed throughout the School of Health Sciences, and participation will be completely voluntary to reduce selection bias. Methods of Data Collection: Written feedback will be collected via an electronic form containing free text response questions. If responses lack sufficient depth, a small number of follow-up interviews or one focus group may be conducted to clarify key issues, minimising participant burden. The form will be hosted on Microsoft Forms within the University of Nottingham secure Microsoft 365 platform, with access restricted to the research team. If written responses lack sufficient depth, a small purposive sample (2-6 participants) may be invited to follow-up interviews or one focus group. Study Sequence and Duration: The data collection tool is designed to balance depth of feedback with minimising participant burden; the estimated completion time is 15-20 minutes. If written responses do not provide sufficient depth to inform revisions, a small subset of participants will be invited to take part in follow up semi structured interviews (approximately 2-6 interviews) or one focus group will be convened to explore specific issues in more detail. Number of participants \& group allocations: The research aims to recruit approximately 20-30 adults aged 18 or over who can read and understand English in accordance with feasibility research standards. This sample size is adequate for identifying recurring issues relating to clarity, accessibility, and acceptance while keeping data volume manageable for thematic analysis. Methods of Data Analysis: Qualitative data will be analysed using Braun and Clarke's (2006) reflexive thematic analysis. An inductive approach will allow unanticipated themes to emerge, appropriate for the study's exploratory aims. Analysis will involve familiarisation, initial coding (focusing on clarity, accessibility, tone, and burden), theme development, review, and refinement, followed by defining and naming final themes. Reflexive notes will document analytic decisions throughout. Readability scores will be integrated with qualitative interpretations by examining sections identified as challenging alongside participant feedback. This combined approach supports triangulation and enhances the credibility and depth of findings. Recruitment Recruitment will take place through online advertisements, email circulation, and other low risk public facing channels. No direct approach or targeted recruitment of vulnerable groups will occur. Information provided to participants: A study invitation explaining the purpose of the research, what participation involves, that participation is voluntary, and the anticipated time commitment will be included in the recruitment materials. The invitation will be sent out through departmental mailing lists and, if applicable, staff communication platforms or internal virtual learning environments. The recruitment message will make it clear that participation is completely voluntary. A Participant Information Sheet (PIS) will be sent to prospective participants who indicate interest. The aims, ethical approvals, research activities involved in the study and the researcher's and supervisor's contact information will all be provided in this document. The feedback form will only be accessible to those who have given their informed consent. This recruitment strategy reduces the possibility of perceived pressure, especially in situations where staff-student power relations may present and is consistent with ethical guidelines for low-risk university-based research. Informed Consent: Informed consent will be obtained prior to any data collection and will be completed electronically. Participants will be given adequate time to read the PIS before deciding whether to take part. Contact details for the researcher and supervisor will be provided so that participants can ask questions or request clarification before consenting. Consent will be recorded using a single online consent form. This form will include consent for: * participation in the written feedback component, and * being contacted for an optional follow-up interview or focus group, should further clarification be required. Participants must actively confirm each consent statement (e.g. by ticking mandatory boxes) before proceeding. Data collection will not be possible unless consent has been provided. Participation in any follow-up interview or focus group remains voluntary. Participants will be required to confirm consent before being interviewed or before taking part in an interview or focus group (as applicable). Participant confidentiality: The study staff will safeguard the privacy of participants' personal data. The study will comply with the General Data Protection regulation (GDPR) Data Protection Act 2018, which requires all personal data to be anonymised as soon as it is practical to do so. The processing of the personal data will be minimised by making use of a unique study ID number only on all study documents and any electronic database(s). Documents (such as consent forms) that contain identifying data and/or information allowing this to be linked to the participant ID will be stored separately under strict access controls. All documents will be stored securely and only accessible by study staff and authorised personnel. If participants agree for their contact details to be kept for the purpose of inviting them to take part in future research studies, their name, contact details will be stored on a separate database under strict access controls. Discontinuation/ withdrawal of participants from study: Participants may withdraw from the study at any time without giving a reason and without consequence. They may choose to: * Withdraw from further involvement but allow data collected up to that point to be retained; or * Withdraw and request deletion of their identifiable data, provided this occurs before anonymisation. Once data has been anonymised, it will no longer be possible to remove an individual's contribution. This includes transcripts of audio recordings and focus group data, where individual comments cannot be separated without compromising the dataset. These limits will be explained in the PIS. Definition of end of study The end of participant involvement in the study is the date of submission of feedback and if needed the date of an interview or focus group session.