How readable are orthognathic surgery consent forms?

How readable are orthognathic surgery consent forms?
Original Article
Maurice J.Meade, Craig W. Dreyer
International Orthodontics, 16 September 2022
Summary
Background/objective
The valid consent process for medical intervention requires the disclosure of information in a format that is easily understandable by the patient. The aim of this investigation was to assess the readability of orthognathic surgery informed consent forms (OSICFs).
Methods
An online search methodology was conducted to identify OSICFs for analysis. The forms that satisfied inclusion/exclusion criteria were evaluated according to a standardised protocol. The readability of the content was assessed using three validated tools: the Simple Measure of Gobbledegook (SMOG) score, Flesch-Kincaid Grade-Level (FKGL) score and Flesch Reading Ease (FRE) score.
Results
Most of the 26 evaluated OSICFs were sourced from websites within the United States (69.2%) and from oral and maxillo-facial surgery practices (76.9%). Two of the assessed forms were template OSICFs available from oral and maxillo-facial professional societies to its members. The scores from the three tools found that the content of 84.6% to 92.3% of the forms were “difficult” to read. The mean (SD) SMOG score for all evaluated OSICFs was 12.31(2.22) [95% CI: 11.42 to 13.21]. The SMOG and FKGL scores were closely correlated (r = 0.99, P < 0.0001; 95% CI: 0.9864 to 0.9973). There was no association between SMOG scores and the number of words contained within each consent form (r = −0.047;95% CI: −0.44 to 0.36).
Conclusions
The OSICFs surveyed in this investigation failed to meet recommended readability levels. A significant number of patients are not likely to understand the information contained within the forms. Orthodontists are advised that poor literacy skills of their patients may preclude them from validly consenting to orthognathic surgery treatment procedures.

Concepts in Emergency Research Exception from Informed Consent

Concepts in Emergency Research Exception from Informed Consent
Book Chapter
Christine S. Cocanour, Isabelle A. Struve
The Acute Management of Surgical Disease, 16 September 2022; pp 113–123 [Springer]
Abstract
Informed consent is an ethical concept, codified in the law, and is in daily practice at every healthcare institution. It is the process of communication between patients and treating physicians that results in an agreement that allows the treating physician to perform a specific medical intervention. A valid informed consent requires disclosure, capacity, and voluntariness. In the emergency setting this consent process is not possible. Ethical concerns involving subjects who cannot provide consent was a barricade to emergency research. Standard, accepted medical therapy was not tested for either safety or efficacy in the emergency setting. In recognition of this potential harm, the government eventually permitted exception from informed consent in certain emergency research trials in order to (1) provide individuals in life-threatening situations access to potentially life-saving therapies, (2) advance knowledge through collection of information about effectiveness and safety, and (3) improve therapies used in emergency medical situations that currently have poor clinical outcomes. This chapter will explore the history behind informed consent, informed consent for human subject research, and exception from informed consent (EFIC)/waiver of informed consent (WIC).

An evaluation of patient informed consent for dental extractions

An evaluation of patient informed consent for dental extractions
Richa Arya, Sarah Jadun, Aneesha Shah
Primary Dental Surgery, 7 September 2022; 11(3)
Abstract
Dental practitioners are well versed in informing patients of the risks and benefits associated with dental extractions. The purpose of this service evaluation was to determine whether patients understood and recalled information relevant to their planned oral surgery procedure, prior to second stage consent. A questionnaire was distributed to patients who were attending for their elective treatment appointment. This explored their ability to recall the planned intervention, the modality of treatment (local anaesthetic, intravenous sedation, or general anaesthetic), understanding of alternative treatment options and the risks associated with the procedure. Completed responses were received from 29 of the distributed questionnaires (response rate=58%). The majority of patients were not aware of the following risks with their procedure: pain, bleeding, bruising, swelling, infection, damage to adjacent structures. Despite a well-documented consent form and comprehensive discussion, we identified that patients may not comprehend or recollect the risks associated with their dental extraction. As dental professionals we have a duty to seek ways to facilitate patient understanding and maximise their autonomy.

Fertility clinic consent forms and the disposition of reproductive material upon a fertility patient’s death

Fertility clinic consent forms and the disposition of reproductive material upon a fertility patient’s death
Legal reflections
D W Thaldar
South African Medical Journal, September 2022; 112(9) pp 744-746
Open Access
Abstract
South African fertility clinics often include a provision in their consent forms that deals with the disposition of reproductive material (gametes and embryos) after a fertility patient’s death. This practice is problematic as such a provision is not legally valid. If the clinic acts in pursuance of such a provision upon a fertility patient’s death, the fertility clinic may be committing a civil wrong and a crime. Accordingly, consent forms should not include any provision that deals with the disposition of reproductive material after a fertility patient’s death. Instead, to address the practical concern of keeping reproductive material cryopreserved without receiving payment, fertility clinics’ storage agreements should use non-payment by fertility patients (or their successors in title) as the trigger event for the disposition of reproductive material. The importance of dealing with reproductive material in both its property rights dimension and its personality rights dimension is highlighted.

Patient experience and decisional satisfaction with the informed consent process for elective gynecologic surgeries: A cross-sectional study

Patient experience and decisional satisfaction with the informed consent process for elective gynecologic surgeries: A cross-sectional study
Glaiza S.de Guzman, Melissa D.L. Amosco
Annals of Medicine and Surgery, September 2022; 81
Abstract
Background
The informed consent process is a vital component of daily medical practice. It involves providing patients with sufficient, accurate, and understandable information to decide on a contemplated therapy. The study aims to evaluate the patient experience and satisfaction with the preoperative informed consent process.
Methods
A cross-sectional study was performed on adult women admitted for elective gynecologic surgery in a tertiary training hospital. Participants were recruited on their second postoperative day and were asked to answer a structured questionnaire assessing decisional satisfaction and experience with the informed consent process. Satisfaction was measured using a 6-item Satisfaction with Decision Scale. Knowledge of the surgery and experience with the informed consent were measured using an Informed Consent Questionnaire. Bivariate associations between highly satisfied and not highly satisfied groups were tested using Fisher exact test.
Results
A total of 150 patients were enrolled in the study with a mean age of 44.5 years. The resident-in-charge provided the information and assisted in the documentation of the informed consent in 86.7% and 67.3% of patients, respectively. There was an overall high decisional satisfaction with a mean score of 27.4 and 52.7% of patients strongly agreeing to all statements of the Satisfaction with Decision Scale. The majority of the respondents were informed and acknowledged comprehension of the surgery including its risks, benefits, and alternative treatment options. Knowing the success rate and benefits of the procedure as well as being informed of the need for postoperative catheterization were significantly associated with high satisfaction.
Conclusion
Knowledge and understanding of the key components of informed consent influence patient satisfaction. The current study highlights the high decisional satisfaction rates of patients who underwent elective gynecologic surgery. Strategies to further improve this patient-physician encounter include the establishment of standard policies on personnel involved, timing, and quality of information given to patients. Patient satisfaction should serve as an indicator of the quality of healthcare rendered and guide for continuous improvement of services.

Towards a Design Toolkit of Informed Consent Models Across Fields: A Systematic Review

Towards a Design Toolkit of Informed Consent Models Across Fields: A Systematic Review
Original Research/Scholarship
Iris Loosman, Philip J. Nickel
Science and Engineering Ethics, 30 August 2022; 28(42)
Open Access
Abstract
In the 60+ years that the modern concept of informed consent has been around, researchers in various fields of practice, especially medical ethics, have developed new models to overcome theoretical and practical problems. While (systematic) literature reviews of such models exist within given fields (e.g., genetic screening), this article breaks ground by analyzing academic literature on consent models across fields. Three electronic research databases (Scopus, Google Scholar, and Web of Science) were searched for publications mentioning informed consent models. The titles, abstracts, and if applicable, full publications were screened and coded. The resulting data on fields, models, and themes were then analyzed. We scanned 300 sources from three databases to find 207 uniquely named consent models, and created a network visualization displaying which models occur primarily in one field, and which models overlap between fields. This analysis identifies trends in the consent debate in different fields, as well as common goals of consent models. The most frequently occurring consent models are identified and defined. The analysis contributes toward a cross-disciplinary “consent design toolkit” and highlights that there are more interrelationships between models and fields than are acknowledged in the literature. Where some models are designed to solve distinctively field-specific issues and are specific to biomedical ethics, some may be adaptable and applicable for other fields including engineering and design.

Informed Consent: A Monthly Review
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September 2022 :: Issue 45

This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_September 2022

Digital Home Health During the COVID-19 Pandemic Challenges to Safety, Liability , and Informed Consent, and the Way to Move Forward

Digital Home Health During the COVID-19 Pandemic Challenges to Safety, Liability , and Informed Consent, and the Way to Move Forward
Faculty Books
Sara Gerke
Dickinson Law Idea, 2022
Open Access
Introduction
Artificial intelligence (AI) and other digital health products, such as smart pills, are rapidly entering clinical practice. We live in the age of big data, where massive amounts of data are collected and used to develop or update digital health products and are shared with third parties for research or commercial purposes. Moreover, we can already see a shift in health care from hospitals to people’s homes, for example through the use of medical apps, Fitbits, and other wearables. This line between clinic and home will likely become more and more blurry in the near future. According to one estimate, the smart home health care market size is projected to grow from $6.1 billion in 2018 to over $30 billion in 2025. In particular, the COVID-19 pandemic has propelled the adoption of health AI and digital health across multiple applications. For example, the development and use of digital home health products have been expedited to reduce exposure to the coronavirus SARS-CoV-2, such as through remote patient monitoring, and to better control its spread, such as through exposure-notification apps. At the same time, the regulation of medical devices is more flexible during the public health emergency. However, the acceleration of launching new digital home health devices on the US market combined with less regulatory oversight also raises some challenges, including post-pandemic questions. In this chapter, I will first give an overview of the promise of digital home health. I will then discuss the regulation of digital home health before and during COVID19 in the context of the US Federal Food, Drug, and Cosmetic Act (FDCA). This will be followed by a discussion of three digital home health challenges during the pandemic: 1) safety, 2) liability, and 3) informed consent. In this context, I will also make suggestions on how to move forward.

A Census of Clinical Trials Conducted Under the US Exception from Informed Consent Rule

A Census of Clinical Trials Conducted Under the US Exception from Informed Consent Rule
Krista L. Snyder, Jon F. Merz
medRxiv, 24 August 2022
Abstract
Background
The US Food and Drug Administration and National Institutes of Health adopted the Exception from Informed Consent (EFIC) rule in 1996, permitting waiver of informed consent for certain emergency research, including trials funded by the federal government. The rule requires that prospective consent be sought when practicable from patients or their Legally Authorized Representative(s) (LAR), and for those enrolled without consent, the patient or their LAR must be given information and an opportunity to opt-out from continued participation at the earliest opportunity. We sought to census the trials conducted under the EFIC rule to facilitate research to better understand how the rule is being used.
Methods
We conducted a multi-pronged search to try and identify all trials conducted under the EFIC rule, drawing on numerous reviews, Medline and Google searches (including of the clinicaltrials.gov registry), examination of the FDA’s docket, posting an inquiry on the IRB Forum, and email requests to lead authors of all published EFIC trials and related review articles. We describe the trials, when they were started and completed, and whether they were terminated early.
Results
We identified a total of 105 trials as of April 1, 2022: 77 complete, 10 recruiting, 10 registered on clinicaltrials.gov but not yet recruiting, 5 trials that were abandoned before enrolling any subjects, and 3 trials in early planning. Nine of the 77 completed trials were pilot or feasibility trials. Of 68 completed full trials, 30 (44.1%) were terminated early. The most common reason for early termination was futility or safety (17 trials, 25.0%) followed by poor recruitment (9 trials, 13.2%). The rate of conduct of trials has been remarkably constant since 2001, with roughly 18 trials started in each 5-year period.
Conclusions
The rate of early termination of EFIC trials for futility or safety appears higher than for other kinds of clinical research. We provide the list of trials in a Supplement for further in-depth data collection and analysis of this set of trials.

Use Of Teach-Back During Informed Consent In Cancer Clinical Trials

Use Of Teach-Back During Informed Consent In Cancer Clinical Trials
Christa Varnadoe
Yale School of Nursing Digital Theses, 2022
Open Access
Abstract
Five percent of the 1.8 million patients diagnosed with cancer in the United States (US) enroll annually in a clinical trial (American Cancer Society, 2021; Institute of Medicine Committee on Cancer Clinical Trials; National Cancer Institute Cooperative Group Program, 2010). Flawed research consent practices are detrimental to patient safety and costly to the US Healthcare system (Eisenberg et al., 2012; Unger et al., 2019). Well trained nurses are imperative to conducting rigorous, reproducible, and quality research (Brandt et al., 2011). Programs designed to educate nurses on how to implement comprehensive communication strategies confidently during the Cancer Clinical Trials (CCT) consent process remain scarce (Nusbaum et al, 2019; Purdom et al., 2017). The purpose of this quality improvement project was to develop, implement, and evaluate the effects of an evidenced-based education program on nurse confidence with use of the teach-back method during the CCT consent process. An evidenced based education program was developed. It was implemented as a synchronous webinar to members of the International Association of Clinical Research Nurses. Pre and post test program surveys measuring confidence levels were disseminated. There was an overall increase in postsurvey responses suggesting an improvement in confidence levels with use of the teach-back method during the CCT IC process. Further study can explore if patient understanding of CCTs during the IC process is developed proportionally to levels of nurse confidence with use of the teach-back method.