Improving Consent in Trauma: Recall (ICIT: Recall): a multicentre study protocol of consent for hip fractures

Improving Consent in Trauma: Recall (ICIT: Recall): a multicentre study protocol of consent for hip fractures
Tony Feng, Andrew Ablett, Chloe E H Scott, Nick D Clement
Bone & Joint Open, 13 March 2025
Open Access
Abstract
Aims
This study investigates the effectiveness and adequacy of the informed consent process for patients undergoing hip fracture surgery. While informed consent is a legal and ethical responsibility, factors in the trauma setting can impair patients’ understanding and retention of information. This study seeks to evaluate patients’ recall of perioperative complications and explore their perceptions of the consent process.
Methods
A mixed-methods, multicentre cohort study will be conducted in the Southeast of Scotland. Adult patients with hip fractures will be recruited via consecutive sampling. An information recall questionnaire will be administered within 36 hours of admission to assess unprompted and prompted recall of complications. A subset of participants will then undergo a semi-structured qualitative interview postoperatively to explore their experiences and perceptions of the consent process. Data will be analyzed using a social constructivist grounded theory to assess their perceptions of consent. Ethical approval has been granted by the East of England Research Ethics Committee (reference 23/EE/0233).
Conclusion
Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences. The study results will identify challenges in the consent process, particularly in how risks are communicated and understood. The data are expected to inform the development of information aids and enhance the ability of orthopaedic surgeons to provide comprehensive, patient-centred consent.

Obtaining Written Informed Consent for the Administration of Local Anesthetics in Dentistry in 2024, a 20-Year Follow-Up Study

Obtaining Written Informed Consent for the Administration of Local Anesthetics in Dentistry in 2024, a 20-Year Follow-Up Study
Research Article
Daniel L. Orr, Zane P. Jenkins, Timothy M. Orr
Anesthesia Progress, 12 March 2025
Abstract
Objective
This study revisited data obtained in 2004 regarding whether dentists routinely obtain informed consent (IC) for the administration of local anesthetics and compared those findings with newer data obtained in 2024.
Methods
A previous survey from 2004 which utilized 3 questions including identification of provider type (generalist or specialist) and whether IC is always obtained for local anesthetic administration was replicated in 2024. While the 2004 survey was performed on paper, the 2024 survey was done via a brief oral interview. Both efforts were completed at the annual meetings of The American Dental Society of Anesthesiology (ADSA) in Las Vegas, NV.
Results
A total of 249 respondents opted to participate in the 2024 survey as compared with the 252 respondents from 2004. During the past 20 years, the number of dentists who reported always obtaining IC for the administration of local anesthetics appears to have increased significantly. A total of 196 (79%) of the 2024 participants reported always obtaining IC for local anesthesia compared with 158 (63%) in 2004. Except for dentists limiting their practice to anesthesiology, all other provider categories reported an increase in IC use from 2004 to 2024, and specialists still reported obtaining IC for local anesthesia more frequently than generalists.
Conclusion
The prevalence of including local anesthetic administration with the IC process is increasing in the profession. It is likely that generalists administer many more local anesthetics than specialists overall. The IC subject matter is too nuanced to recommend a single “yes or no” treatment plan as the standard of care for all clinical situations.

A Novel Strategy for Understanding What Patients Value Most in Informed Consent Before Surgery

A Novel Strategy for Understanding What Patients Value Most in Informed Consent Before Surgery
Gillie Gabay, Attila Gere, Glenn Zemel, Howard Moskowitz
Healthcare, 28 February 2025
Open Access
Abstract
Background/Objectives
To map and analyze patient expectations regarding communication in IC and identify communication that both heightens anxiety in the IC process and reduces anxiety in the IC process before surgery.
Methods
Ethics approval was granted. A power analysis indicated a required sample of 90 patients. A conjoint-based experimental design was performed, post-discharge, overcoming typical biases of surveys.
Results
The sample comprised 104 patients who underwent surgery in the last year. Three verbal communication messages were perceived as significantly decreasing pre-operative anxiety for the total sample. Mathematical clustering yielded three distinct mindsets. Post hoc ANOVA indices indicated that the mindsets were significantly different. Patients belonging to each mindset differed from patients belonging to other mindsets in their expectations from the dialogue with surgeons to mitigate their anxiety. Mindset 1 (70% of the sample) comprised patients who expected information that was tailored to their specific situation. To feel safer, they needed to know that nothing unexpected would happen. Mindset 2 (13%) comprised patients who expected providers to talk with them about benefits and risks at the clinic, not at the hospital, and have a dialogue with them. Mindset 3 (17%) comprised patients who perceived a lack of information regarding the purpose of signing the informed consent and lack of sufficient time to thoroughly read the form or signing the form minutes before the procedure as elements that would heighten their anxiety.
Conclusions
Three verbal communication messages in the IC dialogue were thought to decrease pre-operative anxiety for all patients, as follows. “I want to make sure you read and understand the consent form entirely” “Everything is provided in clear and simple terms”. The surgeon says, “Let’s go over the entire form”.

The impact of inadequate disclosure and patient recall on the consent process in neurosurgery: A systematic literature review

The impact of inadequate disclosure and patient recall on the consent process in neurosurgery: A systematic literature review
Ashraf Elmahdi, David Smith
Surgeon, February 2025
Abstract
Background
The informed consent process in neurosurgery aims to uphold patient autonomy and provide comprehensive information for decision-making. However, gaps in communication and understanding between patients and surgeons persist. This systematic review examined the impact of consent on neurosurgical practice, exploring the effectiveness of different consent approaches.
Methods
A comprehensive search of databases and relevant sources identified twenty-eight studies for inclusion. Prospective and retrospective studies were assessed to examine the effect of consent on neurosurgical practice. Data collection and analysis involved independent reviewers assessing eligibility, study quality, and risk of bias. Findings from the included studies were used to write the review.
Main results
Randomized controlled trials specific to the impact of consent in neurosurgery needed to be included. Nevertheless, the reviewed twenty-nine studies revealed a significant risk of litigation due to inadequate information provision. Neurosurgeons’ adherence to the standard of competent peers was identified as crucial in bridging the gap between desired and actual patient-surgeon interactions.
Authors conclusions
This review underscores the need to address communication gaps between patients and surgeons within the informed consent process in neurosurgery. Neurosurgeons must strive to meet the standard of competent peers and implement effective consent strategies involving multiple modalities. Enhancing communication and patient comprehension can mitigate potential litigation risks, ensuring better patient-centred care and shared decision-making in neurosurgical practice.

Is consent to psychological interventions less important than consent to bodily interventions?

Is consent to psychological interventions less important than consent to bodily interventions?
Lisa Forsberg, Thomas Douglas, Julian Savulescu
The Philosophical Quarterly, 27 February 2025
Abstract
It is standardly accepted that medical interventions can be permissibly administered to a patient who has decision-making capacity only when she has given her valid consent to the intervention. However, this requirement for valid medical consent is much less frequently discussed in relation to psychological interventions (‘PIs’) than it is in relation to bodily interventions (‘BIs’). Moreover, legal and professional consent requirements in respect of PIs are laxer than the analogous requirements in respect of BIs. One possible justification for these differences appeals to the Differential Importance View—the view that it is presumptively morally less important to obtain explicitly given valid consent for PIs than for BIs. In this article, we argue against the Differential Importance View by considering and rejecting three possible justifications for it. These invoke differences between PIs and BIs with respect to implicit consent, risk, and wrongfulness.

Informed Consent: A Monthly Review
_________________

March 2025 :: Issue 75

In preparing this digest, we monitor a broad range of academic journals and utilize Google Scholar to search articles referencing  informed consent or assent. After careful consideration, a selection of these results appear in the digest. We also monitor other research, analysis, guidance and commentary beyond the academic literature globally, including calls for public consultation and symposia/conferences which address consent/assent in whole or in part. We recognize that some of the arguments presented in this edition may be controversial and may warrant closer scrutiny. We have elected to be generous in our inclusion with the goal of presentating of a wholistic landscape of informed consent literature as it is being published. 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: Center for Informed Consent Integrity – A Monthly Review_March 2025

Pulling Out the Rug on Informed Consent — New Legal Threats to Clinicians and Patients

This month we have chosen to highlight an article which appeared in the New England Journal of Medicine, Pulling Out the Rug on Informed Consent — New Legal Threats to Clinicians and Patients, reflecting the impact of changes in US law on informed consent. In their perspective piece, Underhill and Nelson write about the change to Utah’s Malpractice Act which allows the retroactive withdrawal of consent given as a minor, leaving clinicians vulnerable to future litigation. We are highlighting this article as we are concerned about the intersection of politics and ideology here. Consent is an important to the patient as to the physician, and the role of consent should not be used to further an agenda. We are reaching out to the authors to explore potential pathways forward.

Pulling Out the Rug on Informed Consent — New Legal Threats to Clinicians and Patients
Perspective
Kristen Underhill, Kimberly M. Nelson
New England Journal of Medicine, 1 February 2025
Abstract
A legal technique deployed by Utah to restrict gender-affirming care for minors aims at a core component of the clinician–patient relationship: clinicians’ ability to rely on patients’ informed consent.
Excerpt
   In recent years, state legislators in large portions of the United States have devised and enacted new legal strategies to limit access to health care for transgender people. To date, 26 states have enacted outright bans on gender-affirming care, which thus far apply only to minors. Other state laws create financial or procedural obstacles to this type of care, such as bans on insurance coverage, requirements to obtain opinions from multiple clinicians, or consent protocols that are stricter than those for other health care…
Allowing patients to withdraw their consent retroactively is an acute threat to the legal infrastructure supporting U.S. healthcare. Informed-consent requirements exist to ensure that patients have the information and agency to participate in their own healthcare. They also protect clinicians. In all practice areas, clinicians expect to rely on patients’ consent at the time of care, without having to guess which patients will later change their minds. If laws eliminate clinicians’ ability to rely on consent at the time of care, the resulting legal instability may undermine access to all types of health care services. Pulling out the rug on informed consent threatens the core of the clinician–patient relationship. Clinicians in every area should recognize that these laws are not just attacking gender-affirming care — they are attacking the foundation of the U.S. health care system.

Verbal Consent in Biomedical Research: Moving Toward a Future Standard Practice?

Verbal Consent in Biomedical Research: Moving Toward a Future Standard Practice?
Review Article
Alycia Noe, Emilie Vaillancourt, Ma’n H Zawati
Frontiers in Genetics, 12 February 2025
Abstract
Properly obtaining informed consent is a core obligation for research conducted using human subjects. The traditional informed consent process involves written forms and obtaining signatures. This process remains the standard, but in various research settings, such as COVID-19 and rare disease research, verbal consent has increasingly become the norm. Although verbal consent is used in these settings, its use is still a subject of debate. This article reviews in what medical settings verbal consent is commonly seen today, various advantages and disadvantages of verbal consent, and its legislative and policy ecosystem. In doing so, this review article asserts that it is time for the debate over verbal consent to come to an end and for legislator and policymakers to acknowledge its use and to formalize the process. This will allow verbal consent to be regulated in a similar manner to written consent and will give clinician-researchers guidance on how to better implement verbal consent in their studies to addressing ongoing concerns with the consenting process as a whole.

Editor’s Note: We note that if verbal consent is employed there must also be a record of this transaction, either by way of recording or transcription, to allow for adequate documentation.

The Use of Electronic Consent (eConsent) Within the Ketamine for Long-Lasting Pain Relief After Surgery (KALPAS) Multicenter Trial

The Use of Electronic Consent (eConsent) Within the Ketamine for Long-Lasting Pain Relief After Surgery (KALPAS) Multicenter Trial
Lisa V Doan, Jeri Burr, Raven Perez, Hamleini Martinez, Randy Cuevas, Kevin Watt, Jing Wang
Journal of Pain Research, 4 January 2025
Abstract
Background
The informed consent process has traditionally taken place in person. The introduction of electronic consent (eConsent) has made remote consenting processes possible. Use of eConsent has increased since the COVID-19 pandemic. It has streamlined the process of consenting patients and has been shown to benefit the research study team and participants.
eConsent in the Ketamine Analgesia for Long-Lasting Pain Relief After Surgery (Kalpas) Study
The KALPAS study is a multicenter, double-blind, randomized controlled study investigating the effectiveness of ketamine in reducing chronic post-mastectomy pain in women undergoing mastectomy for oncologic indication. The study uses a two-part consent form consisting of a master consent with information applicable to all sites and site-specific information. All potential participants receive the full two-part consent form for review. When signing the eConsent, however, all potential participants are provided with a concise summary of the informed consent document, an approach not widely used by multicenter studies. eConsent has been noted to be beneficial to research staff when trying to gather informed consent from participants who live far away from the hospital, want to include their family and friends, and for researchers who can approach patients outside of their clinical appointments.
Conclusion
The ability to consent patients remotely has allowed for a flexible workflow within sites and a more patient-centric process that focuses on including loved ones in the discussion and scheduling time to speak to a principal investigator. Demand for eConsent will likely continue in the post-COVID era, and use of a concise summary can allow for a more efficient consenting process.

Impact of informed consent quality on illness uncertainty among patients with cancer in clinical trials: a cross-sectional study

Impact of informed consent quality on illness uncertainty among patients with cancer in clinical trials: a cross-sectional study
Original Article
Sihan Kang, Jie Zhang, Dong Pang , Hong Yang, Xiaohong Liu, Renxiu Guo, Yuhan Lu
Asia-Pacific Journal of Oncology Nursing, 20 February 2025
Open Access
Abstract
Objective
This study aimed to examine the level of illness uncertainty and the quality of informed consent among patients with cancer participating in clinical trials and explore their interrelationship.
Methods
A cross-sectional study was conducted with 265 patients with cancer recruited from a tertiary hospital in Beijing, China, from April to November 2023. Participants completed a questionnaire encompassing demographic details, the Mishel Uncertainty in Illness Scale, and the Quality of Informed Consent Questionnaire. Descriptive statistics, correlation analyses, and multiple regression analyses were performed to assess the data.
Results
The mean illness uncertainty score was 40.63 ± 10.12, reflecting a moderately low level of uncertainty, with “Ambiguity” scoring the highest among its dimensions. The mean score for informed consent quality was 3.30 ± 1.20, indicating a moderate level of understanding, with notable gaps in elements such as alternatives and confidentiality. A significant negative correlation was found between the “Foreseeable risks or discomforts” element of informed consent and overall illness uncertainty (P < 0.05). Regression analysis revealed that factors such as clinical trial phase, primary caregiver relationship, and health insurance model significantly influenced illness uncertainty and its dimensions.
Conclusions
Enhancing the quality of informed consent can effectively reduce illness uncertainty among patients with cancer in clinical trials. Greater emphasis should be placed on clear communication of risks and discomforts and patient-centered interventions to mitigate psychological stress.