The 2018 Common Rule revision intended to improve informed consent by recommending a concise key information (KI) section, yet provided little guidance about how to describe KI. We developed innovative, visual KI templates with attention to health literacy and visual design principles. We explored end users’ attitudes, beliefs, and institutional policies that could affect implementing visual KI pages.

From October 2023 to April 2024, we conducted semi-structured interviews with principal investigators, research staff, and Institutional Review Board (IRB) personnel, including those in oversight/management, and community partners. Forty participants from three academic institutions (in the Midwest, Southeast, and Mountain West) viewed example KI pages and completed interviews. We coded written transcripts inductively and deductively based on the capability, opportunity, and motivation to change behavior (COM-B) framework. Data were analyzed using content analysis and organized thematically.

Participants responded positively to the visual KI examples. They discussed potential benefits, including improving information processing and understanding of study procedures, diversity in research, trust in research, and study workflow. They also described potential challenges to consider before widespread implementation: IRBs’ interpretations of federal guidelines, possible impacts on IRB submission processes, the effort/skill required to develop visuals, and difficulty succinctly communicating study risks. There was no consensus about when to use visual KI during consent, and some wondered if they were feasible for all study types.

Visual KI offers a promising solution to long-standing informed consent challenges. Future work can explore resources and training to address challenges and promote widespread use.

Clinical research trials rely on informed consent forms (ICFs) to explain all aspects of the study to potential participants. Despite efforts to ensure the readability of ICFs, concerns about their complexity and participant understanding persist. There is a noted gap between Institutional Review Board (IRB) standards and the actual readability levels of ICFs, which often exceed the recommended 8th-grade reading level. This study evaluates the readability of over five thousand ICFs from ClinicalTrials.gov in the USA to assess their literacy levels.

We analyzed 5,239 US-based ICFs from ClinicalTrials.gov using readability metrics such as the Flesch Reading Ease, Flesch-Kincaid Grade Level, Gunning Fog Index, and the percentage of difficult words. We examined trends in readability levels across studies initiated from 2005 to 2024.

Most ICFs exceeded the recommended 8th-grade reading level, with an average Flesch-Kincaid Grade Level of 10.99. While 91% of the ICFs were written above the 8th-grade level, there was an observable improvement in readability, with fewer studies exceeding a 10th-grade reading level in recent years.

The study reveals a discrepancy between the recommended readability levels and actual ICFs, highlighting a need for simplification. Despite a trend toward improvement in more recent years, ongoing efforts are necessary to ensure ICFs are comprehensible to participants of varied educational backgrounds, reinforcing the ethical integrity of the consent process.

Intranasal cocaine is commonly used in endoscopic sinus surgery due to its vasoconstrictive and anaesthetic properties. This study aimed to understand patients’ perspectives and whether patients should have to give their consent for its use.

Prospective data were collected over a three-month period in ENT departments in the out-patient setting of two district general hospitals. An anonymous questionnaire was distributed to all adult patients asking for their thoughts on cocaine use in sinonasal surgery and the need for peri-operative discussion.

In total, 123 patient questionnaires were analysed. It was found that 9.8 per cent of patients knew of cocaine use in sinonasal surgery, 73.2 per cent of patients stated they would like a pre-operative discussion on cocaine use before surgery and 83.1 per cent of patients raised concerns over cocaine's illicit status, mainly its effect on work and driving. Only 34 per cent of patients said that they would prefer an alternative to cocaine.

This study found that patients want to know if and when cocaine is being used intra-operatively without necessarily objecting to it.

Most otolaryngologists advocate absolute voice rest after laryngeal surgery, which proves difficult for patients, so we decided to evaluate the role of absolute voice rest versus relative voice rest in the post-operative management of benign lesions.

Forty patients were recruited and divided in two groups: absolute voice rest and relative voice rest. Pre- and post-operative voice analysis (fundamental frequency, jitter, shimmer, voice handicap index, voice-related quality-of-life scale scores and compliance) were noted at one week and one month.

Voice analysis parameters including jitter (p = 0.035), shimmer (p = 0.020), voice handicap index (p < 0.001) and compliance (p < 0.001) were better in the relative voice-rest group. Frequency, number of voice breaks and voice-related quality of life showed no statistically significant results.

There was no significant benefit of absolute voice rest on post-operative outcomes as determined by acoustic variables. Compliance and quality-of-life scores were low in the strict voice-rest group. Therefore, we should reconsider post-surgical voice-rest protocol.

Informed consent for surgery is a complex process particularly in paediatrics. Complexity increases with procedures such as CHD surgery. Regulatory agencies outline informed consent contents for surgery. We assessed and described CHD surgical informed consent contents through survey dissemination to paediatric CHD centres across United States of America.

Publicly available email addresses for 125 paediatric cardiac clinicians at 70 CHD surgical centres were obtained. Nine-item de-identified survey assessing adherence to The Joint Commission informed consent standards was created and distributed via RedCap® 14 March, 2023. A follow-up email was sent 29 March, 2023. Survey link was closed 18 April, 2023.

Thirty-seven surveys were completed. Results showed informed consent documents were available in both paper (25, 68%) and electronic (3, 8%) format. When both (9, 24%) formats were available, decision on which format to use was based on centre protocols (1, 11%), clinician personal preference (3, 33%), procedure being performed (1, 11%), or other (4, 45%). Five (13%) centres’ informed consent documents were available only in English, with 32 (87%) centres also having a Spanish version. Review of informed consent documents demonstrated missing The Joint Commission elements including procedure specific risks, benefits, treatment alternatives, and expected outcomes.

Informed consent for CHD surgery is a complex process with multiple factors involved. Majority of paediatric CHD surgical centres in the United States of America used a generic informed consent document which did not uniformly contain The Joint Commission specified information nor reflect time spent in discussion with families. Further research is needed on parental comprehension during the informed consent process.

To compare visual estimation versus ImageJ calculation of tympanic membrane perforation size in the paediatric population between clinicians of different experience.

Five images of tympanic membrane perforations in children, captured using an otoendoscope, were selected. The gold standard was the ImageJ results by one consultant otologist. Consultants, registrars and Senior House Officers or equivalent were asked to visually estimate and calculate the perforation size using ImageJ software.

The mean difference in variation from gold standard between visual estimation and ImageJ calculation was 12.16 per cent, 95 per cent CI (10.55, 13.78) p < 0.05, with ImageJ providing a more accurate estimation of perforation. Registrars were significantly more accurate at visual estimation than senior house officers. There was no statistically significant difference in ImageJ results between the different grades.

Using ImageJ software is more accurate at estimating tympanic membrane perforation size than visual assessment for all ENT clinicians regardless of experience.