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Consent forms play an active role in the consent process with generic, handwritten consent forms (GCF) often the standard across the National Health Service. Increasingly, procedure-specific consent forms (PSCF) are being used as an alternative. However, concerns remain about whether they meet the standard for consent. We therefore conducted a systematic review with the objectives of investigating evidence for PSCF, study methodology and medicolegal criteria. This systematic review was prospectively registered on PROSPERO (CRD42023392693) and conducted from 1 January 1990 to 17 March 2023 using the MEDLINE, Embase, CINAHL, CENTRAL and Emcare databases. A grey literature search was also performed. All studies evaluating PSCF in medical and surgical settings were included. Risk-of-bias analysis was performed using 'RoB 2' and 'ROBINS-I'. Meta-analysis was not possible because of the results' heterogeneity. We identified 21 studies investigating PSCF with no systematic reviews and meta-analyses reported. Most studies were quality improvement projects ( = 10) followed by randomised studies ( = 5). No definitive legal guidance for PSCFs and no studies assessing their role in litigation post-procedural complications were identified. PSCFs were associated with improved documentation (70%-100%; = 11) and legibility (100%; = 2) compared with GCF. Randomised studies ( = 4) investigating patient understanding and recall for PSCF were inconclusive compared with GCF. The heterogeneous evidence available merely demonstrates superior documentation of PSCF compared with GCF. Studies do not adequately investigate the impact on informed consent and fail to address the associated legal concerns. Further randomised studies with patient-centric outcomes and consideration for medicolegal criteria are needed.

Informed consent is the cornerstone of human research subject protection. Many subjects sign consent documents without understanding the study purpose, procedures, risks, benefits, and their rights. Proof of comprehension is not required and rarely obtained. Understanding might improve by using an interactive system with multiple options for hearing, viewing and reading about the study and the consent form at the subject's own pace with testing and immediate feedback. This prospective randomized study compared the IRB-approved paper ICF for an actual clinical research study with an interactive presentation of the same study and its associated consent form using an iPad device in two populations: clinical research professionals, and patients drawn from a variety of outpatient practice settings. Of the 90 participants, 69 completed the online test and survey questions the day after the session (maximum 36 hours post-session). Among research professionals (n = 14), there was a trend (p = .07) in the direction of iPad subjects testing better on the online test (mean correct  =  77%) compared with paper subjects (mean correct = 57%). Among patients (n = 55), iPad subjects had significantly higher test scores than standard paper consent subjects (mean correct = 75% vs 58%, p < .001). For all subjects, the total time spent reviewing the paper consent was 13.2 minutes, significantly less than the average of 22.7 minutes total on the three components to be reviewed using the iPad (introductory video, consent form, interactive quiz). Overall satisfaction and overall enjoyment slightly favored the interactive iPad presentation. This study demonstrates that combining an introductory video, standard consent language, and an interactive quiz on a tablet-based system improves comprehension of research study procedures and risks.

Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised consent forms (both in summary and detailed formats) endorsed by the British Orthopaedic Association (BOA) were retrieved from orthoconsent.com and assessed for readability. This involved using an online tool to calculate the validated Flesch reading ease score (FRES). This was compared with the FRES for the National Health Service (NHS) Consent Form 1. Data were analysed and interpreted according to the FRES grading table. Results The FRES for Consent Form 1 was 55.6, relating to the literacy expected of an A level student. The mean FRES for the BOA summary consent forms (n=27) was 63.6 (95% confidence interval [CI]: 61.2-66.0) while for the detailed consent forms (n=32), it was 68.9 (95% CI: 67.7-70.0). All BOA detailed forms scored >60, correlating to the literacy expected of a 13-15-year-old. The detailed forms had a higher FRES than the summary forms (p<0.001). Conclusions This study demonstrates that the BOA endorsed standardised consent forms are much easier to read and understand than the NHS Consent Form 1, with the detailed BOA forms being the easiest to read. Despite this, owing to varying literacy levels, a significant proportion of patients may struggle to give informed consent based on the written information provided to them.

Informed consent is a fundamental element of research ethics. The COVID-19 vaccine trials are high profile trials that have enrolled more than 100 000 participants. Consent documents must be succinct and understandable to ensure informed voluntary participation. To assess how well informed consent documents of the COVID-19 vaccine trials achieve the ideal of being succinct and understandable, and to create a shorter, more readable document. This quality improvement study collected and analyzed the informed consent documents used in 4 COVID-19 vaccine phase III randomized clinical trials to quantitatively assess readability and length and, based on this analysis, created a measurably more accessible informed consent document. Analysis was conducted from October 2020 to January 2021. The main outcomes were number of words (measured as word count), time-to-read (measured at reading speeds of 175-300 words per minute), language complexity (measured using Flesch-Kincaid Grade Level assessment), and readability (measured using Flesch Reading Ease Score). Secondary outcomes included clarity of how the placebo group could access the vaccine if it is proven safe and effective. The study also examined the length and readability of an improved consent document. The 4 informed consent documents were a mean (range) of 8333 (7821 to 9340) words long, with a mean (range) 35 (32.6 to 38.9) minutes to read at 240 words per minute. All documents exceeded grade 9 language complexity and scored lower than 60 in the formal reading ease metric, which constitutes difficult. Only 1 document specified that participants in the placebo group might receive vaccine. It was possible to write a document in fewer than 3000 words with a grade 7 to 8 reading level and a formal readability score that was not difficult. These findings suggest that existing COVID-19 vaccine informed consent documents were too long, difficult to read, and exceeded grade 9 in language complexity. It was possible to create a shorter, more readable informed consent document for these trials.

Background Informed consent is a legal and ethical prerequisite for elective procedures such as total knee arthroplasty (TKA). However, standard informed consent forms often lack evidence-based content and do not adequately support informed decision-making. The aim was to develop and pilot test an evidence-based informed consent form for TKA. Methods We conducted a two-phase study. In Phase 1, we developed an extended, evidence-based informed consent form for TKA, as well as a corresponding form for anaesthesia, based on systematic evidence syntheses, expert reviews, and standards outlined in the Guideline Evidence-based Health Information . We also developed an e-learning program to train clinicians in the appropriate use of informed consent forms. In addition, we developed a multiple-choice test to assess patients’ knowledge and risk perception. In Phase 2, we piloted the informed consent forms with potential patients through think-aloud interviews and focus groups, assessing their acceptability, usability and comprehensibility with iterative revisions. The multiple-choice test was also piloted and revised. Qualitative data were analysed using qualitative content analysis. Results We developed evidence-based informed consent forms for TKA and anaesthesia. Content and risk communication follow the Guideline Evidence-based Health Information and meet legal requirements under German law. Benefits and complications were presented using natural frequencies and visualised with bar charts. The forms were piloted in six think-aloud and three focus group interviews with 17 participants. Feedback from participants and experts highlighted the need for revisions in the presentation of numerical data, terminology, structure and layout, which were addressed iteratively. Overall, the forms were rated as understandable, relevant and helpful, though individual information needs varied. The 12-item multiple-choice knowledge test was revised to improve clarity and was perceived as comprehensible and applicable. The e-learning programme includes videos, texts and interactive elements, and is designed for flexible use over 90 to 180 min. Conclusions The informed consent forms are now available. Evidence-based informed consent forms are feasible and perceived by patients as helpful and understandable. The variety of patients’ information needs underlines the need for personalised counselling and structural adjustments in clinical practice so that the potential of evidence-based informed consent forms can be exploited.

High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10-19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation.

Surgical consent forms convey critical information; yet, their complex language can limit patient comprehension. Large language models (LLMs) can simplify complex information and improve readability, but evidence of the impact of LLM-generated modifications on content preservation in non-English consent forms is lacking. This study evaluates the impact of LLM-assisted editing on the readability and content quality of surgical consent forms in Korean-particularly consent documents for standardized liver resection-across multiple institutions. Standardized liver resection consent forms were collected from 7 South Korean medical institutions, and these forms were simplified using ChatGPT-4o. Thereafter, readability was assessed using KReaD and Natmal indices, while text structure was evaluated based on character count, word count, sentence count, words per sentence, and difficult word ratio. Content quality was analyzed across 4 domains-risk, benefit, alternative, and overall impression-using evaluations from 7 liver resection specialists. Statistical comparisons were conducted using paired 2-sided t tests, and a linear mixed-effects model was applied to account for institutional and evaluator variability. Artificial intelligence-assisted editing significantly improved readability, reducing the KReaD score from 1777 (SD 28.47) to 1335.6 (SD 59.95) (P<.001) and the Natmal score from 1452.3 (SD 88.67) to 1245.3 (SD 96.96) (P=.007). Sentence length and difficult word ratio decreased significantly, contributing to increased accessibility (P<.05). However, content quality analysis showed a decline in the risk description scores (before: 2.29, SD 0.47 vs after: 1.92, SD 0.32; P=.06) and overall impression scores (before: 2.21, SD 0.49 vs after: 1.71, SD 0.64; P=.13). The linear mixed-effects model confirmed significant reductions in risk descriptions (β₁=-0.371; P=.01) and overall impression (β₁=-0.500; P=.03), suggesting potential omissions in critical safety information. Despite this, qualitative analysis indicated that evaluators did not find explicit omissions but perceived the text as overly simplified and less professional. Although LLM-assisted surgical consent forms significantly enhance readability, they may compromise certain aspects of content completeness, particularly in risk disclosure. These findings highlight the need for a balanced approach that maintains accessibility while ensuring medical and legal accuracy. Future research should include patient-centered evaluations to assess comprehension and informed decision-making as well as broader multilingual validation to determine LLM applicability across diverse health care settings.

Regarding medico-legal malpractice suits, lawyers and insurers focus on informed consent documentation. Unfortunately, there is no standard protocol for obtaining informed consent for platelet-rich plasma (PRP) injections. The objective of the present study was to create a pre-designed, evidence-based informed consent form specifically for PRP injections. The current evidence on the medico-legal implications of PRP injections was accessed, as well as informed consent in general and specifically informed consent in PRP injections. Additionally, we interviewed orthopaedic surgeons and patients who had undergone PRP injections in the past year using a semi-structured approach. A legally valid and evidence-based informed consent form for PRP injections ensures rights, encouraging open communication and transparency between the patient and surgeon. Moreover, if a lawsuit arose, informed consent would be a critical document in surgeons' defence and would withstand scrutiny from lawyers and the judiciary. An evidence-based informed consent form for PRP injections was elaborated and reviewed by a legal expert to ensure adherence to legal proprieties. The final form of the informed consent for PRP injection was administered for one year and validated at our institution.

Guidelines on informed consent intend to protect patients and promote ethical research conduct. To give informed consent, individuals should understand the purpose, process, risks, benefits, and alternatives to research (or a proposed clinical intervention) and make a free, voluntary decision about whether to participate. Many participants have incomplete understanding of various features of clinical trials. Issues associated with the length, format, and language of documents for written informed consent are common. Here, we analyse the written consent form, particularly in the context of clinical research, and the discussions that take place between clinician or investigator and patient. We review strategies to improve consent forms, particularly the use of plain language. Recommendations are made on discussions between investigator and patient to improve participant comprehension and satisfaction with the informed-consent process.

Background: This study evaluated the effect of a simplified informed consent form for clinical trials on the understanding and efficacy of informed consent information across health literacy levels. Methods: A total of 150 participants were randomly assigned to one of two groups and provided with either standard or simplified consent forms for a cancer clinical trial. The features of the simplified informed consent form included plain language, short sentences, diagrams, pictures, and bullet points. Results: Levels of objective and subjective understanding were significantly higher in participants provided with simplified informed consent forms relative to those provided with standard informed consent forms. The interaction effects between type of consent form and health literacy level on objective and subjective understanding were nonsignificant. Conclusion: Simplified informed consent was effective in enhancing participant’s subjective and objective understanding regardless of health literacy.