Consent for withholding life-sustaining treatment in cancer patients: a retrospective comparative analysis before and after the enforcement of the Life Extension Medical Decision law
Yu Jin Chung, Incheol Park, Junho Cho, Jin Ho Beom, Ji Eun Lee
BMC Medical Ethics, 17 June 2021; 22(72)
The Life Extension Medical Decision law enacted on February 4, 2018 in South Korea was the first to consider the suspension of futile life-sustaining treatment, and its enactment caused a big controversy in Korean society. However, no study has evaluated whether the actual implementation of life-sustaining treatment has decreased after the enforcement of this law. This study aimed to compare the provision of patient consent before and after the enforcement of this law among cancer patients who visited a tertiary university hospital’s emergency room to understand the effects of this law on the clinical care of cancer patients.
This retrospective single cohort study included advanced cancer patients aged over 19 years who visited the emergency room of a tertiary university hospital. The two study periods were as follows: from February 2017 to January 2018 (before) and from May 2018 to April 2019 (after). The primary outcome was the length of hospital stay. The consent rates to perform cardiopulmonary resuscitation (CPR), intubation, continuous renal replacement therapy (CRRT), and intensive care unit (ICU) admission were the secondary outcomes.
The length of hospital stay decreased after the law was enforced from 4 to 2 days (p = 0.001). The rates of direct transfers to secondary hospitals and nursing hospitals increased from 8.2 to 21.2% (p = 0.001) and from 1.0 to 9.7%, respectively (p < 0.001). The consent rate for admission to the ICU decreased from 6.7 to 2.3% (p = 0.032). For CPR and CRRT, the consent rates decreased from 1.0 to 0.0% and from 13.9 to 8.8%, respectively, but the differences were not significant (p = 0.226 and p = 0.109, respectively).
After the enforcement of the Life Extension Medical Decision law, the length of stay in the tertiary university hospital decreased in patients who established their life-sustaining treatment plans in the emergency room. Moreover, the rate of consent for ICU admission decreased.
(Un)informed Consent: To What Degree are Research Participants ‘Informed’ by Common Consent Procedures in Psychology under EU Data Protection Law?
Malte Elsonab, Dara Hallinanc, Annika Külpmanna, Franziska Boehmc
PsychArchives, 31 May 2021
There is reason to believe that consent forms may routinely do not fulfill the requirements for consent outlined in EU data protection law. Where this is the case, the legitimacy of the conduct of research may be undermined and could result in restrictions on the subsequent conduct of research, obligations to delete data, or obligations to limit the sharing of psychological research data. However, so far, there are no empirical data to support the proposition that compliance may not be the norm. We propose a study design in which we draw a random sample of psychological research reports and systematically compare the research practices (i.e., reported data collection procedures, sharing practices) with the details provided in the respective participant information and consent form and compare each of these with the legal requirements outlined in EU data protection law.
Presumed Consent for Organ Donation: An Incoherent Justification
Vicente Formoso, Sílvia Marina, Miguel Ricou
Acta Bioethica, 2021; 27(1) pp 27-35
The difference between supply and demand of transplantable organs is a global problem, and one of the most discussed measures aiming to solve it is the implementation of a presumed consent (opt-out) policy in cadaveric organ donation. This type of system is controversial when it comes to its direct effects on organ donation rates as well as its ethical base. We aim to present the latest perspectives concerning the ethical implications of the policy, especially regarding consent: its need, the coherence of presuming it and the policy’s capacity to fulfill its requirements. From a community perspective, we advocate a default change in societies with an opt-out system, with a strong population education in that direction. The potential rights of family objection are also approached as well as the differences between theoretical discussion and concrete application of public policy.
Egyptian patients’/guardians’ experiences and perception about clinical informed consent and its purpose: Cross sectional study
Ammal M. Metwally, Hala A. Amer, Hend I. Salama, Safaa I. Abd El Hady, Raefa R. Alam, Ahmed Aboulghate, Hanan A. Mohamed, Hanan M. Badran, Amal A. Saadallah, Marwa M. El-Sonbaty, Eman Eltahlawy, Walaa Saad, Amira Mohsen, Ghada A. Abdel-Latif, Asmaa M. Fathy, Amal I. Hassanain, Abdelmoneim Eldali
PLoS One, 14 June 2021
Informed consent (IC) is a healthcare standard emphasizing the meaning of human dignity as clarified in the Universal Declaration of Human Rights. Data about IC practices in Egypt is insufficient. This study aimed to assess the Egyptian patients’/guardians’ experiences about IC and their expectations about its practices’ purposes in general and according to the type of the healthcare facility.
Self-administered questionnaire was carried out for 1092 participants who had undergone or were scheduled to a procedure requiring an IC at three studied types for Egyptian health care facilities. Ten statements were ranked twice by the participants to reflect their perception of IC purpose as per what is currently practiced and what they believe should be practiced.
IC implementation varies significantly (p<0.05) across the health care facilities in Egypt. The percentage of its implementation at the non-governmental facilities, governmental facilities, and university hospital was 85.9%, 77.8%, and 63.8 respectively. The first three ranked purposes of the current IC practices were: “Helping patient/guardian decide (64.9%)”, “Documenting patient’s/guardian’s decision (59.3%)”, and “Having shared decision (57.3%)”. The perceived purposes of IC to be practiced were: “Informing the patient/guardian (68.4%)”, “Making sure patient/guardian understand (65.3%)” and “Documenting patients/guardians decisions (65.1%)”. “Being a meaningless routine” was reported by the majority to be ranked as a low purpose for IC current and preferred practices.
The practice of IC is common within the Egyptian medical community. Participants believe that information disclosure “Making sure patients understand” has to help in IC decision making and its main purpose. However, unfortunately, this is not perceived as a current purpose of IC. There was consensus agreement that documenting the patient’s/guardian’s decision and informing the patient/guardian are perceived as both important current and preferred purposes for IC practices.
Promoting Patient Engagement in Medical Informed Consent – A Qualitative Study of Chinese Doctors’ Communication Strategies
Qianwen Joyce Yu, ack Pun
Health Communication, 3 June 2021
Patient engagement is now widely endorsed as an essential ingredient for high-quality healthcare, yet there has been limited research on how patient engagement can be facilitated in medical informed consent (IC) communication. To address this gap, a fine-grained discourse analysis was conducted to identify communication strategies adopted by doctors to facilitate information delivery and ascertain patients’ understanding, which translate into an increase in patient engagement. Data was collected from a public hospital in mainland China. Nonparticipating observations of 14 IC sessions were audio-recorded, followed by in-depth, semi-structured interviews with those observed patients. Four communication strategies emerged from the analysis: 1) seeking patients’ understanding of their condition; 2) explaining medical information by reference to shared knowledge and practice; 3) recognizing and addressing patients’ psychological concerns; 4) repeating critical information and checking patients’ understanding through teach-back. The adoption of these strategies enables doctors to tailor the scope and delivery of information to accommodate and address patients’ preferences, rather than defaulting to one-way information dumping. This study sheds light on the complexity of IC and further contributes to the ongoing endeavors to improve IC communication by raising the awareness of the role of patients in making mutually acceptable decisions. These identified strategies can be incorporated into medical communication training to facilitate delivery of healthcare that is sensitive to patients’ needs and expectations.
Autonomy and consent assessment for electroconvulsive therapy (ECT). A retrospective study of medical records
Jørgen Dahlberg Siri Øverstad, Vegard Dahl, Alina Coman
International Journal of Law and Psychiatry, July–August 2021; 77
The Norwegian Mental Health Act allows involuntary treatment for patients who lack consent capacity, however it allows only administration of pharmaceutical treatment and nutrition and not ECT. In lack of specific regulations, the legal access to ECT without valid consent has been grounded on the general rule of necessity in the Norwegian Penal code. This restriction and lack of legal regulation has implications for patients’ rights and legal security.
The study’s aim was to assess the documented consent provided by patients for electroconvulsive therapy (ECT), whether ECT was administered without valid consent or under coercion, and the documented reasons, and ultimately compare practice with the legal requirements. We analysed systematically all the relevant medical records for hospitalised patients and outpatients receiving ECT during 2011–2016. We categorized data from these two groups into seven defined categories describing the attitude and quality of the consents to the ECT (or lack thereof).
378 patients received 498 ECT series´. The noted consents varied from treatment based on request (54 treatments), consent upon recommendation (209 treatments), consent after hesitation (88 treatments), consent presumed or noted without specification (114 treatments), to no consent (21 treatments) whereof the majority with documented coercion applied (19 treatments). All cases of ECT without consent referred to a “plea of necessity”. The remaining treatments (12) lacked notifications specifying the consent (or attitude) expressed. Specific notes on the patient’s capacity to consent for the respective ECT were generally lacking.
This study indicates a large spread in patients´ acceptance and valid consent to ECT. The main reason for administering ECT without consent and/or against patients’ will was for life-saving reasons. Such treatments were justified legal under a plea of necessity in the Penal Code or lacked noted legal justification. The legal vacuum for ECT without a valid consent needs to be addressed as this kind of disputed treatment is used in some cases.
Junior doctor experiences and challenges in obtaining surgical informed consent: A qualitative systematic review & meta-ethnography
Josephine de Costa, Mandy Shircore, Alande Costa
Journal of Surgical Research, November 2021; 267 pp 143-150
Surgical informed consent (SIC) to procedures is necessary to ensure patient autonomy is adequately respected. It is also necessary to protect doctors, and their institutions, from claims of negligence. While SIC is often acquired by senior consultants, it also commonly falls to the junior doctors on a team to ensure SIC is adequately acquired and documented. A growing body of literature suggests that junior doctors are not sufficiently educated about the legal and practical issues concerned with obtaining medical consent. This may open up this cohort, and their hospitals, to medico-legal liability.
to provide a systematic review of the qualitative literature on junior doctors’ experiences and challenges in consenting surgical patients and to synthesize evidence on this issue in order to guide policy-makers in the medicolegal and medical education spheres.
a systematic review of qualitative literature was performed. Analysis of the literature was guided by Noblit and Hare’s seven-step approach to meta-ethnography, with the final synthesis presented as a thematic analysis of the literature.
This research concludes that a significant proportion of SIC is likely to be acquired by junior doctors, many of whom are Post-Graduate Year (PGY) 1-2 and who lack adequate training and education. This cohort face challenges in assessing capacity, in ensuring adequate disclosure related to surgical procedures, and in adequately documenting consent. This may impact the validity of any SIC they acquire. Medical educators and policy-makers should be aware of these issues when creating policies impacting SIC, and when designing surgical education programs for medical students and junior doctors alike.
Principles related to informed consent in functional and aesthetic rhinoplasty: A prospective study
Aloua Rachid, Sabr Ayoub, Kerdoud Ouassime, Opoko Ulrich, Savadogo Sayouba, Belem Ousmane, Konsem Tarcissus, Slimani Faiçal
International Journey of Surgery Open, 17 June 2021
Rhinoplasty is one of the most complex surgical procedures in plastic surgery.
Patient requirement is often mixed, aesthetic and functional, for resolution of functional respiratory problems is therefore as important as correction of nasal deformity. Informed consent in rhinoseptoplasty is a difficult process because of the complexity of the operative technique, which presents a wide range of potential complications.
Patients and method
Type of study: This is a prospective, descriptive study conducted in the department of oral and maxillofacial surgery. Fifty-two patients, who consulted for rhinoplasty, participated in the study. Patients were informed about the complications commonly discussed during the consent process in rhinoplasty surgery. Each patient was contacted one month after the initial consultation to assess recall of complications and acceptance of surgery.
The aim of our study is to highlight the importance of informed consent in rhinoplasty surgery in terms of complications, and to identify gaps in the consent process.
Confidence level, challenges, and obstacles faced by orthopedic residents in obtaining informed consent
Abdulaziz Z. Alomar
Journal of Orthopaedic Surgery and Research, 17 June 2021; 16(390)
The objective is to evaluate the opinions of orthopedic residents on current practices, experiences, training, confidence level, difficulties, and challenges faced when obtaining informed consent.
This is a cross-sectional, multi-center, and questionnaire-based study.
The study was done in forty-four training centers across Saudi Arabia.
In total, 313 orthopedic residents participated.
Material and methods
The web-based questionnaire examined the perceptions of residents regarding practices, experience, training, difficulties, and challenges surrounding the obtention of informed consent, as well as residents’ confidence in obtaining informed consent for different orthopedic situations and eight common orthopedic procedures.
Most residents were allowed to obtain consent independently for all emergency, trauma, primary, and revision cases at their institution (92.7%). Only 33.5% of the residents received formal training and teaching on obtaining informed consent, with 67.1% having believed that they needed more training. Only 4.2% of the residents routinely disclosed all essential information of informed consent to patients. Inadequate knowledge (86.3%) and communication barriers (84.7%) were the most reported difficulties. Generally, 77.3% of the residents described their confidence level in obtaining informed consent as good or adequate, and 33.9% were confident to discuss all key components of the informed consent. Residents’ confidence level to independently obtain informed consent decreased with procedure complexity. Receiving formal training, senior level (postgraduate year (PGY) 4 and 5), and being frequently involved in obtaining informed consent correlated with increased confidence level.
Many residents incompletely disclosed key information upon obtaining informed consent and reported lacking confidence in their ability to perform the procedure in their daily practices. To improve patient care and residents’ performance and overcome these difficulties and challenges, institutions should develop effective strategies to standardize the informed consent process, provide formal training for obtaining informed consent, and provide supervision for residents during obtention of informed consent.
Obstetrician–Gynecologists’ Practices in Postpartum Sterilization Without a Valid Medicaid Consent Form
Kavita Shah Arora, Roselle Ponsaran, Laura Morello, Leila Katabi, Rosemary T. Behmer Hansen, Nikki Zite, Kari White
Obstetrics & Gynecology, 10 June 2021
To explore the practices of obstetrician–gynecologists (ob-gyns) in the United States surrounding postpartum sterilization when the Medicaid consent form was not valid.
Using the American College of Obstetricians and Gynecologists’ online directory, we conducted a qualitative study where we recruited ob-gyns practicing in 10 geographically diverse U.S. states for a qualitative study using semi-structured interviews conducted by telephone. We analyzed interview transcripts using the constant comparative method and principles of grounded theory.
Thirty ob-gyns (63% women, 77% nonsubspecialized, and 53% academic setting) were interviewed. Although most physicians stated that they did not perform sterilizations without a valid Medicaid sterilization form, others noted that they sometimes did due to a sense of ethical obligation toward their patient’s health, being in a role with more authority or seniority, interpreting the emergency justification section of the form more broadly, or backdating the form. The physicians who said that they never went ahead without a signed form tended to work at large institutions and were concerned with losing funding and engaging in potentially illegal or fraudulent behavior.
Physicians’ varied behaviors related to providing postpartum sterilization without a valid Medicaid consent form demonstrate that the policy is in need of revision. Unclear terminology and ramifications of the Medicaid sterilization policy need to be addressed to ensure equitable care.