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
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
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
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.
Trustworthiness as information: Satisfying the understanding condition of valid consent
Trustworthiness as information: Satisfying the understanding condition of valid consent
Martin RK
Bioethics, 21 March 2023
Abstract
Within medical ethics, there is widespread agreement that morally valid consent includes an understanding condition. Disagreement centers on what is meant by that understanding condition. Tom Dougherty proposed that this understanding condition should be divided into the two mutually exclusive categories of descriptive information and contextual information. Further, Dougherty argues that each type of information is necessary to satisfy the understanding condition. In contrast, I argue that when the deontic aspect of valid consent is in view, each type of information can be sufficient to satisfy the understanding condition on its own. Moreover, by analyzing delegation, which is conceptually related to consent since both are morally transformative actions, I show that delegation often depends not on descriptive or contextual information but on trust. So, I argue that trustworthiness can also be a type of information that does the same work as descriptive and contextual information in satisfying the understanding condition for valid consent.
Editor’s note: The referenced article by Tom Do can be found here.
Consent and Trust in the Doctor Patient Relationship
Consent and Trust in the Doctor Patient Relationship
Book Chapter
Philipp Bonhoeffer, Federico Festa, Lamia Ait Ali, Pierluigi Festa
The Patient as a Person, 21 March 2023 [Springer]
Abstract
Trust, defined as an assured reliance on the character, ability, strength, or truth of someone or something is an immensely precious subject matter in medicine. However, the historical doctor/patient relationship based on trust alone has shown important shortcomings. Consequently, the medical consent developed for the interest and legal protection of patients. This in turn led to a vulnerability of doctors who then needed to defend themselves whenever litigation occurred. As a result, the formal medical consent has rapidly shifted in its application as a protection to health professionals, far removed from its original purpose. Vigilance and trust need to be carefully balanced. After educating patients for years to be vigilant about wrong doings of doctors, patients have lost the clear benefit and comfort that trust brings in a good patient–doctor relationship. It is known that trust plays a major role in the healing process. Trust, therefore is a good thing and there is no reason why the positive effect of trust should be neglected in classical medicine.
Misconceptions about the Doctrine of Informed Consent in the Medical Profession
Misconceptions about the Doctrine of Informed Consent in the Medical Profession
Kelvin Christie, Maurice A. Dean, Isiah Lyma
Research Developments in Medicine and Medical Science, 4 March 2023; pp 136-157
Abstract
This article focuses on common misunderstandings in healthcare regarding how physicians and medical researchers apply the doctrine of informed consent. The specific myth addressed has to do with the level of care expected of medical professionals when treating patients. This paper also explains how the legal history of informed consent has led to misconceptions about informed consent as applied to both medical researchers and medical physicians. There has long been a public misconception that medical researchers are subject to a lower standard of care than medical doctors in cases involving informed consent. We argue that this misconception is largely attributed to the fact that statutes, ethical regulations, guidelines, and legal precedents within the medical and research profession are governed by two separate bodies of laws and regulatory guidelines. Furthermore, informed consent in the medical setting has traditionally been enacted primarily from case law, while informed consent in the research setting has primarily been enacted from statutory law and regulations.
Informed Consent: A Monthly Review
_________________
March 2023 :: Issue 51
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_March 2023
Patients acceptance and comprehension to written and verbal consent (PAC–VC)
Patients acceptance and comprehension to written and verbal consent (PAC–VC)
Robert C. Welsh, Shane Kimber, Justin Ezekowitz, Rabia Kashur
BMC Medical Ethics, 23 February 2023; 24(14)
Open Access
Abstract
Background
Acute myocardial infarction (AMI) research is challenging as it requires enrollment of acutely ill patients. Patients are generally in a suboptimal state for providing informed consent. Patients’ understanding to verbal assents have not been previously examined in AMI research. Patients’ Acceptance and Comprehension to Written and Verbal Consent (PAC–VC) compared patients’ understanding and attitudes to verbal and written consents in AMI RCTs.
Methods
PAC–VC recruited patients from 3 AMI trials using both verbal N = 12 and written N = 6 consents. We compared patients’ understanding using two survey questionnaires. The first questionnaire used open-ended questions with multiple choice answers. The second questionnaire used a 5-point Likert scale to measure patients understanding and attitudes to the consent process. Overall answers average scores were categorized into three groups: Adequate understanding (71–100) %, Partial understanding (41–70)% and Inadequate understanding (0–40)%.
Results
Responses showed patients with verbal assent had adequate understanding to most components of informed consent, close to those of written consent. Most patients did not read written information entirely and believed that it is not important to make a final decision. Patients favoured to have written information be part of the consent but not necessarily presented during the initial consent process. Patients felt less pressured in the verbal assent arm than those of written consent.
Conclusion
Patients had adequate understanding to most components of verbal assent and comparable to those of written consent. Utilizing verbal assents in the acute care setting should be further assessed in larger trials.
Electronic informed consent: effects on enrolment, practical and economic benefits, challenges, and drawbacks—a systematic review of studies within randomized controlled trials
Electronic informed consent: effects on enrolment, practical and economic benefits, challenges, and drawbacks—a systematic review of studies within randomized controlled trials
Review
Ana Teresita Mazzochi, Martin Dennis, Ho-Yan Yvonne Chun
Trials, 21 February 2023; 24(127)
Open Access
Abstract
Background
Enrolment is one of the most challenging aspects of conducting clinical trials, preceded by the process of informed consent (IC). Different strategies to improve recruitment in clinical trials have been used, including electronic IC. During COVID-19 pandemic, barriers to enrolment have been evident. Although digital technologies were acknowledged as the future of clinical research and potential advantages were shown for recruitment, electronic informed consent (e-IC) has not yet been globally adopted. The purpose of this review is to investigate the effect of using e-IC on enrolment, practical and economic benefits, challenges, and drawbacks when compared to traditional informed consent, through a systematic review.
Methods
Embase, Global Health Library, Medline, and The Cochrane Library databases were searched. No limit was set for publication date, age, sex, or study design. We included all studies within a randomized controlled trial (RCT), published in English, Chinese or Spanish, evaluating the electronic consent process used in the parent RCT. Studies were included if any of the three components ((i) information provision, (ii) participant’s comprehension, (iii) signature) of the IC process was designed as electronic, whether administered remotely or face-to-face. The primary outcome was the rate of enrolment to the parent trial. Secondary outcomes were summarized according to the various findings reported on the use of electronic consent.
Results
From a total of 9069 titles, 12 studies were included in the final analysis with a total of 8864 participants. Five studies of high heterogeneity and risk of bias showed mixed results on the efficacy of e-IC on enrolment. Data of included studies suggested e-IC could improve comprehension and recall of study-related information. Meta-analysis could not be conducted due to different study designs and outcome measures and the predominantly qualitative findings.
Conclusion
Few published studies have investigated the impact of e-IC on enrolment and findings were mixed. e-IC may improve participant’s comprehension and recall of information. High-quality studies are needed to evaluate the potential benefit of e-IC to increase clinical trial enrolment.
Center for Informed Consent Integrity 