Comparison of the Structured Consent Process Using Modified Delphi Technique with the Standard Process in Obtaining Informed Consent for Procedures in ENT by PHASE III MBBS Students
Original Article
Sapna Sreedharan Nambiar
Indian Journal of Otolaryngology and Head & Neck Surgery, 15 March 2023
Open Access
Abstract
Communication skill is a core competency and the training must begin in the undergraduate period itself. The Phase III MBBS students during their ENT posting are required to obtain informed consent for procedures and surgeries in ENT which forms the basis for efficient communication skills in house-surgency (internship) and residency. Informed consent taking is an important aspect and in the clinical postings, the teaching of communication skills along with history taking and physical examination can go a long way in making a strong foundation to good doctor patient relationships. This study aimed to compare the structured consent process using modified Delphi technique with the standard process in obtaining informed consent for procedures in ENT by PHASE III MBBS students. The need to sensitise the MBBS students on appropriate consent taking procedures with familiarisation of the essential elements of the Kalamazoo consensus statement were raised, accepted and final OSCE assessment attributes decided by the modified Delphi technique. The Modified Delphi technique is a unique means to obtain opinions of experts across the field in various spheres so as to identify lacunae if any in the existing teaching with means to reach a valid and reliable consensus. Our study included Phase III MBBS students posted to the Department of ENT, Govt Medical College Kozhikode during Jan–Feb 2022 wherein one batch of 30 students were taught with 2 classes on informed consent taking by the structured process obtained after Modified Delphi technique and included as; “MD” group and another batch of 30 students from the entire batch taught by the standard process was included as; “T” group respectively. After completion of the clinical postings an assessment was carried out with OSCE stations in Mar 2022; wherein 10 students were evaluated for each of the 6 common ENT procedures, 5 students from “T” group and 5 students from “MD” group respectively. Median total score of MD group was 6.5 (3.25–8) and median score of T group was 4.5 (2.25–6.75). The difference in mean ranks of these scores was statistically significant, p < 0.0001. The feedback assessment using the questionnaire with Likert scale had all 30(100%) students recommend this method of structured consent taking for enhancement of communications skills. However 20% of the students were not satisfied with the teaching learning method expressing the need for more time allocation and demonstrations. Informed consent taking requires the appropriate training in the undergraduate period itself as seen by the improved OSCE scores on assessment after teaching by the structured consent taking process as well as from the feedback of the students.

ACR–ARS Practice Parameter on Informed Consent Radiation Oncology
Original Article
Hurwitz, Mark D., Chundury, Anupama, Goodman, Chelain R., Jones, Joshua, Lo, Simon S., Saeed, Hina, Small, William Jr, Schechter, Naomi R.
American Journal of Clinical Oncology, 8 March 2023
Abstract
Objectives
Consent is a communication process between the patient and a health care provider, in which both parties have the opportunity to ask questions and exchange information relevant to the patient’s diagnosis and treatment. The process of informed consent is designed to protect a patient’s autonomy in their medical decision-making in the context of an asymmetric relationship with the health care system. A proper consent process assures a patient’s individual autonomy, reduces the opportunity for abusive conduct or conflicts of interest, and raises trust levels among participants. This document was developed as an educational tool to facilitate these goals.
Methods
This practice parameter was produced according to the process described under the heading “The Process for Developing ACR Practice Parameters and Technical Standards” on the ACR website (https://www.acr.org/Clinical-Resources/Practice-Parameters-and-Technical-Standards) by the Committee on Practice Parameters—Radiation Oncology of the ACR Commission on Radiation Oncology in collaboration with the ARS. Committee members were charged with reviewing the prior version of the informed consent practice parameter published in 2017 and recommending additions, modifications, or deletions. The committee met through remote access and subsequently through an online exchange to facilitate the development of the revised document. Focus was given on identifying new considerations and challenges with informed consent given the evolution of the practice of radiation oncology in part driven by the COVID-19 pandemic and other external factors.
Results
A review of the practice parameter published in 2017 confirmed the ongoing relevance of recommendations made at that time. In addition, the evolution of the practice of radiation oncology since the publication of the prior document resulted in the need for new topics to be addressed. These topics include remote consent either through telehealth or telephone and with the patient or their health care proxy.
Conclusions
Informed consent is an essential process in the care of radiation oncology patients. This practice parameter serves as an educational tool designed to assist practitioners in optimizing this process for the benefit of all involved parties.

Evidence-based informed consent form for total knee arthroplasty
Methodology
Satvik N. Pai, Madhan Jeyaraman, Nicola Maffuli, 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.

Patient Information and Consent for Care in the Intensive Care Unit
Review
Jean-Philippe Rigaud, Fiona Ecarnot, Jean-Pierre Quenot
Healthcare, 27 February 2023; 11(5)
Abstract
In this paper, we review the ethical issues involved in providing information to, and obtaining consent (for treatment and/or research) from patients in the intensive care unit. We first review the ethical obligations of the physician in treating patients, who are by definition, vulnerable, and often unable to assert their autonomy during situations of critical illness. Providing clear and transparent information to the patient about treatment options or research opportunities is an ethical and, in some cases, legal obligation for the physicians, but may be rendered difficult, not to say impossible in the intensive care unit by the patient’s health state. In this context, we review the specificities of intensive care with respect to information and consent. We discuss who the right contact person is in the ICU setting, with possible choices including a surrogate decision maker, or a member of the family, in the absence of an officially designated surrogate. We further review the specific considerations relating to the family of critically ill patients, and the amount and type of information that may be given to them without breaching the tenets of medical confidentiality. Finally, we discuss the specific cases of consent to research, and patients who refuse care.

Informed consent in episiotomy: Co-analysis with midwives and distillation of best practice
Jennifer MacLellan, Sara S. Webb, Carmen Byrne, Emily Brace, Elizabeth Glyn-Jones, Elizabeth Edwards, Tracey Hunter, Jacqueline Longton, Jane Cleary, Katie Christie, Lorna Dow, Jo Gould
Birth, 16 February 2023
Open Access
Abstract
Background
Performing an episiotomy where clinically indicated is a key intervention in the Obstetric Anal Sphincter Injury Care Bundle (OASI-CB) implemented across England and Wales to reduce the risk and increase the detection of severe perineal trauma after birth. Standards of consent provided to people in maternity care generally and for episiotomy specifically have been reported as suboptimal. Compromising birthing people’s personal autonomy or sense of control has been linked to a dissatisfying birth experience, negative psychological sequelae, and litigation.
Methods
This study explored experienced midwives’ practice of informed consent for episiotomy during a midwife-led birth. We sampled 43 midwives across eight NHS Trusts in England and Wales using online focus groups and telephone interviews about their experience of consent in episiotomy. Using qualitative content analysis and art-based co-analysis methods with eight midwives from across the research sites, we co-analyzed and co-constructed three themes and four practice recommendations from the data.
Results
Three themes were constructed from the data: Assent rather than consent, Change in culture to support best practice, and Standardized information. These themes informed the shaping of four recommendations for best practice in episiotomy informed consent.
Conclusion
This study has shown how variations in midwifery practice and culture may impact birthing people’s experience of informed consent in episiotomy. Midwives may not have the knowledge or skills to conduct a detailed consent conversation, leading to variation in practice and messages for birthing people. The use of antenatal discussion aids can offer women the opportunity to become informed and fully participate in the decision-making process.

A Well-understood Surgical Informed Consent: A Scoping Review
Rieke Cahya, Adik Wibowo
Unnes Journal of Public Health, January 2023
Open Access
Abstract
The implementation of surgical consent has shifted from simply getting a signature to a focus on doctor-patient communication. Providing adequate information is very important for patients in making decisions so that patients voluntary agree to medical action. Understanding of the medical information that has been provided is the basis for patients to give consent, but in reality many patients find it difficult to understand and doctor fail to administer proper information.The purpose of this scoping review are to evaluate patient’s understanding of the standard surgical informed consent prosess or those given by other methods and to identify factors that influence this patient’s understanding. Three electronic database (ProQuest, ScienceDirect, and Scopus) were used to search literature from 2017 until 2022. A total of 391 articles were identified and 25 articles were selected according to the PRISMA guidelines and the PCC framework. 9 of 11 articles stated that patient understanding level was low. Factors that influence it include education background, age and language limitations. 12 studies (85%) showed that patient understanding improved with the use of additional information media. Overall, the patient’s understanding of surgical informed consent is still low. Communication between doctor and patient plays a big role in it. Various interventions to improve the communication process can be used to improve patient understanding.

Editor’s note: Unnes Journal of Public Health is published by Universitas Negeri Semarang (UNNES) in cooperation with the Association of Indonesian Public Health Experts.