Moral Dilemmas Regarding Physical Restraints in Intensive Care Units: Understanding Autonomy, Beneficence, Non-Maleficence and Justice in the Use of Physical Restraints
Zhou J, Qin Q, Chen S, Zhang H
Journal of Multidisciplinary Healthcare, 28 March 2024
Abstract
In intensive care units, patients are often restrained to ensure their safety, with physical restraints being the most commonly used method. However, physical restraints compromises the patient’s freedom, health and comfort, and nurses often face moral dilemmas when deciding whether to use physical restraints. This article examines physical restraints through the four universal principles of autonomy, beneficence, non-maleficence and justice. Through these principles, the authors will critically explore whether the physical restraints of patients by nurses is ethical in practice and what moral issues exist. This paper also explores conflicts and moral dilemmas for nurses in this context. Finally, suggestions are made on changes to education and clinical practice.

Consent in pregnancy: A qualitative study of the experiences of ethnic minority women
Zahra Khan, Anne Lanceley, Katherine Maslowski, Lily Hutton, Jacqueline Nicholls
Patient Education and Counseling, June 2024
Open Access
Abstract
Objective
Consent in ante-natal and birthing contexts is often challenging, controversial and poorly understood. Increasing evidence indicates that ethnic minority women’s overall experiences of ante-natal care are unsatisfactory, but little is known about their involvement in the consent process. This study aims to explore the views and experiences of ethnic minority women when making decisions requiring their consent.
Design
Qualitative interview study
Setting
A national study conducted in the UK
Sample
Seventeen self-selecting ethnic minority women who had given birth in a UK hospital in the previous 12 months.
Methods
In-depth telephone interviews with seventeen women. A thematic analysis was conducted with a focus on women’s experiences of the consent process.
Results
Three themes were identified. 1. Compromised choice: women experienced limited choice; some women were not asked for their consent at all, or consent was presumed. 2. Pressured consent and silencing: women reported feeling undermined and ‘othered’ based on their ethnicity. 3. Impersonal consent: discussions were impersonal and not tailored to women as individuals; some women suggested that healthcare professionals ignored cultural concerns which were important to them.
Practice Implications
There is an urgent need for healthcare professionals to be supported in actively facilitating consent consultations which enable women from ethnic minority backgrounds to freely voice their concerns and priorities without censure.
Conclusions
This exploratory study is a first step towards understanding how consent is experienced by ethnic minority women. Many women’s experiences reflected failure of healthcare professionals to support genuine choice-making which was perceived to be further undermined by negativity related to women’s ethnicity and cultural identity. There is a need for further research focusing on the consent experiences of specific ethnic minority groups.

Are we gaining valid consent for dental extractions? A retrospective audit on restorability assessment at one dental institution
Research
Melody Shirazi, Jasleen Batra, Maria Devine
British Dental Journal, 15 March 2024
Abstract
Introduction
This paper explores the widely relevant topic of obtaining valid consent in dental practice, focusing on assessing restorability of teeth planned for extraction. The General Dental Council stresses discussing treatment options, benefits and risks for informed decision-making. The study evaluates if pertinent factors, including tooth structure, endodontic status, periodontal health and patient considerations, are considered before consent.
Aim
To ensure restorability has been assessed and all options communicated with patients for completeness of the consent process before tooth extraction.
Objective
To assist clinicians in their systematic assessment of a tooth’s restorability and provide a framework for contemporaneous documentation.
Materials and methods
A two-week retrospective audit of oral surgery outpatients at a dental hospital in London was conducted, analysing the frequency of restorability discussions and patient involvement in decision-making. A simplified restorability guide and educational interventions were introduced to target the set standard of 100% of consenting clinicians to discuss restorability with patients.
Results
Results from two audit cycles show a significant increase in documented restorability discussions and consideration of patient factors.
Discussion
The study recognised restorability assessment subjectivity, thus creating a simplified tool for clinicians. Patients may lack awareness of restorability options, consequences of edentulism, future costs and tooth replacement considerations, emphasising the importance of documented discussions.
Conclusion
Educational interventions and a simplified restorability guide proved beneficial and showed significant improvement in communication with patients regarding restorability and gaining valid consent. Further consideration should be given to barriers patients face when opting for tooth extraction of their restorable teeth, including discussions regarding long-term consequences.

Genetic counselors’ and community clinicians’ implementation and perceived barriers to informed consent during pre-test counseling for hereditary cancer risk
Alexandra Capasso, Bita Nehoray, Nicholas Gorman, Emily A Quinn, Daiana Bucio, Kathleen R Blazer
Journal of Genetic Counselling, 13 March 2024
Abstract
As demand for genetic cancer risk assessment (GCRA) continues to increase, so does the sense of urgency to scale up efforts to triage patients, facilitate informed consent, and order genetic testing for cancer risk. The National Society of Genetic Counselors outlines the elements of informed consent that should be addressed in a GCRA session. While this practice resource aims to improve health equity, research on how well the elements of informed consent are implemented in practice is lacking. This retrospective and prospective mixed-methods study assessed how adequately the elements of informed consent are addressed during pre-test GCRA among 307 community clinicians (CC) and 129 cancer genetic counselors (GC), and barriers they face to addressing these elements. Results revealed that more than 90% of both cohorts consistently addressed components of at least 5 of the 10 elements of informed consent during a pre-test consultation. Technical aspects and accuracy of the test and utilization of test results were the most similarly addressed elements. Notably, GCs more often review the purpose of the test and who to test, general information about the gene(s), and economic considerations whereas CCs more often review alternatives to testing. Both cohorts reported psychosocial aspects of the informed consent process as the least adequately addressed element. Time constraints and patient-related concerns were most often cited by both cohorts as barriers to optimal facilitation of informed consent. Additional barriers reported by CCs included provider lack of awareness, experience, or education, and availability of resources and institutional support. Findings from this study may contribute to the development of alternative delivery models that incorporate supplementary educational tools to enhance patient understanding about the utility of genetic testing, while helping to mitigate the barrier of time constraints. Equally important is the use of this information to develop continuing education tools for providers.

Current Status of Informed Consent Form for Acupotomy in Korean Medicine Hospitals and Development of a Standard Informed Consent Form Using Delphi Method
Original Article
Jihun Kim, Bonhyuk Goo, Hyongjun Kim, Kyoungsuk Seo, Myungjin Oh, Myungseok Ryu, Sang-Hoon Yoon, Kwang Ho Lee, Hyun-Jong Lee, Jungtae Leem, Hyungsun Jun, Jeong Ihn Sook, Sung Woon Choi, Tae Wook Lee, Yeonhak Kim, Yoona Oh, Kunhyung Kim, Gi Young Yang, Eunseok Kim
The Journal of Korean Medicine, 1 March 2024; 45(1) pp 180-199
Abstract
Objectives
This study was conducted to develop a standard acupotomy consent form that takes into account the unique characteristics of Korean Medicine. The study was motivated by the increasing importance of patient autonomy and the growing number of legal disputes related to medical malpractice in the clinical field of Korean Medicine.
Methods
The analysis phase of the study involved a survey of the current status of acupotomy consent forms in Korean Medicine hospitals nationwide. The items of each form were analyzed based on the contents of the Medical law and the standard contract for medical procedures of the Fair Trade Commission (FTC). In the development and evaluation phase, the items and contents of the acupotomy consent form were evaluated using a 5-point Likert scale and content validity was assessed through two rounds of Delphi surveys. In the improvement phase, the contents of the consent form were revised based on the results of a survey of inpatient and outpatient patients in the Department of Acupuncture and Moxibustion at Pusan National University Korean Medicine Hospital, and real-time online meeting. The final version of the standard acupotomy consent form was completed after undergoing proofreading and corrections by a linguistics expert.
Results
Only 30% of Korean Medicine hospitals have implemented acupotomy consent forms. The items of the consent forms did not fully include the items presented in the Medical act and the standard contract for medical procedures of the FTC. To address this issue, two rounds of Delphi surveys and a real-time discussion were conducted with a panel of 12 experts on 27 preliminary items of consent forms. The items and contents that met the criteria for content validity ratio, convergence, and consensus were derived. Based on the derived items and content, a standard acupotomy consent form was developed.
Conclusions
The standard consent form for acupotomy is anticipated to ensure patient autonomy and enhance transparency and liability in acupotomy. Furthermore, it is expected to serve as evidence in case of medical disputes related to acupotomy and contribute as a reference document for the development of standard consents forms for various procedures of Korean Medicine. However, the limitations of the study include that the survey of consent forms was limited to only training hospitals of Korean Medicine, and the standard consent form is only applicable to adults in Korea. Future studies are needed to address these limitations.

Assessing the Readability of Clinical Trial Consent Forms for Surgical Specialties
Amir H. Karimi, Maura R. Guyler, Christian J. Hecht II, Robert J. Burkhart, Alexander J. Acuña, Atul F. Kamath
Journal of Surgical Research, April 2024; 296 pp 711-719
Abstract
Introduction
To evaluate the readability of surgical clinical trial consent forms and compare readability across surgical specialties.
Methods
We conducted a cross-sectional analysis of surgical clinical trial consent forms available on ClinicalTrials.gov to quantitatively evaluate readability, word count, and length variations among different specialties. The analysis was performed between November 2022 and January 2023. A total of 386 surgical clinical trial consent forms across 14 surgical specialties were included.
Results
The main outcomes were language complexity (measured using Flesch–Kincaid Grade Level), number of words (measured as word count), time to read (measured at reading speeds of 240 per min), and readability (measured by Flesch Reading Ease Score, Gunning Frog Index, Simple Measures of Gobbledygook Index, FORCAST, and Automated Readability Index). The surgical consent forms were a mean (standard deviation) of 2626 (1668) words long, with a mean of 12:53 min to read at 240 words per min. None of the surgical specialties had an average readability level of sixth grade or lower across all six indices, and only 16 out of 386 (4%) clinical trials met the recommended reading level. Furthermore, there was no significant difference in reading grade level between surgical specialties based on the Flesch–Kincaid Grade Level and Flesch Reading Ease indices.
Conclusions
Our findings suggest that current surgical clinical trial consent documents are too long and complex, exceeding the recommended sixth-grade reading level. Ensuring readable clinical trial consent forms is not only ethically responsible but also crucial for protecting patients’ rights and well-being by facilitating informed decision-making.

Evidence-based informed consent form for total knee arthroplasty
Methodology
Satvik N. Pai, Madhan Jeyaraman, Nicola Maffulli, Naveen Jeyaraman, Filippo Migliorini & Ashim Gupta
Journal of Orthopaedic Surgery and Research, 2 March 2023
Open Access
Abstract
Introduction
Informed consent documentation is often the first area of interest for lawyers and insurers when a medico-legal malpractice suit is concerned. However, there is a lack of uniformity and standard procedure about obtaining informed consent for total knee arthroplasty (TKA). We developed a solution for this need for a pre-designed, evidence-based informed consent form for patients undergoing TKA.
Materials and methods
We extensively reviewed the literature on the medico-legal aspects of TKA, medico-legal aspects of informed consent, and medico-legal aspects of informed consent in TKA. We then conducted semi-structured interviews with orthopaedic surgeons and patients who had undergone TKA in the previous year. Based on all of the above, we developed an evidence-based informed consent form. The form was then reviewed by a legal expert, and the final version was used for 1 year in actual TKA patients operated at our institution.
Results
Legally sound, evidence-based Informed Consent Form for Total Knee Arthroplasty.
Conclusion
The use of legally sound, evidence-based informed consent for total knee arthroplasty would be beneficial to orthopaedic surgeons and patients alike. It would uphold the rights of the patient, promote open discussion and transparency. In the event of a lawsuit, it would be a vital document in the defence of the surgeon and withstand the scrutiny of lawyers and the judiciary.