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.

Recent revisions to the US Federal Common Rule governing human studies funded or conducted by the federal government require the provision of a “concise and focused” key information (KI) section in informed consent forms (ICFs). We performed a systematic study to characterize KI sections of ICFs for federally funded trials available on ClinicalTrials.gov.

We downloaded ICFs posted on ClinicalTrials.gov for treatment trials initiated on or after the revised Common Rule effective date. Trial records (n = 102) were assessed by intervention type, study phase, recruitment status, and enrollment size. The ICFs and their KI sections, if present, were characterized by page length, word count, readability, topic, and formatting elements.

Of the 102 trial records, 76 had identifiable KI sections that were, on average, 10% of the total length of full ICF documents. KI readability grade level was not notably different from other sections of ICFs. Most KI sections were distinguished by section headers and included lists but contained few other formatting elements. Most KI sections included a subset of topics consistent with the basic elements of informed consent specified in the Common Rule.

Many of the KI sections in the study sample aligned with practices suggested in the preamble to the revised Common Rule. Further, our results suggest that some KI sections were tailored in study-specific ways. Nevertheless, guidelines on how to write concise and comprehensible KI sections would improve the utility and readability of KI sections.