Subtotal Cholecystectomy Results in High Peri-operative Morbidity and Its Risk-Profile Should be Emphasised During Consent
Original Scientific Report
James Lucocq, David Hamilton, John Scollay, Pradeep Patil
World Journal of Surgery, 8 October 2022
Open Access
Abstract
Background
Subtotal cholecystectomy aims to reduce the likelihood of bile duct injury but risks a multitude of less severe, yet significant complications. The primary aim of the present study was to report peri-operative outcomes of subtotal laparoscopic cholecystectomy (SLC) relative to total laparoscopic cholecystectomy (TLC) to inform the consent process.
Method
All laparoscopic cholecystectomies between 2015 and 2020 in one health board were included. The peri-operative outcomes of SLC (n = 87) and TLC (n = 2650) were reported. Pre-operative variables were compared between the two groups to identify risk factors for SLC. The outcomes between the SLC and TLC were compared using univariate, multivariate and propensity analysis.
Results
Risk factors for SLC included higher age, male gender, cholecystitis, increased biliary admissions, ERCP, cholecystostomy and emergency cholecystectomy. Following SLC, rates of post-operative complication (45.9%), imaging (37.9%) intervention (28.7%) and readmission (29.9%) were significant. The risk profile was vastly heightened compared to that of TLC: intra-operative complications (RR 9.0; p < 0.001), post-operative complications [bile leak (RR 58.9; p < 0.001), collection (RR 12.2; p < 0.001), retained stones (RR 7.2; p < 0.001) and pneumonia (RR 5.4; p < 0.001)], post-operative imaging (RR 4.4; p < 0.001), post-operative intervention (RR 12.3; p < 0.001), prolonged PLOS (RR 11.3; p < 0.001) and readmission (RR 4.5; p < 0.001). The findings were consistent using multivariate logistic regression and propensity analysis.
Conclusion
The relative morbidity associated with SLC is significant and high-risk patients should be counselled for the peri-operative morbidity of subtotal cholecystectomy.
Year: 2022
Understanding consent for surgery and for treatment in orthopaedics
Understanding consent for surgery and for treatment in orthopaedics
Editorial
Vane Antolič, Marius M. Scarlat
International Orthopaedics, 30 September 2022; 46 pp 2459–2460
Open Access
Excerpt
Consenting to treatment implies that a person gives permission before receiving any type of medical care, test or examination. The Consent protects the doctor from the accusation of an “unwanted touch”. Surgery is a complex medical act involving treatments, acts, and manoeuvres that could be harmful, although they are expected to be beneficial and amend positively the patient’s health. Prior to obtaining consent for the proposed succession of acts, the surgeon must provide the patient with information about the nature of the treatment, the expected benefits, material risks and adverse effects, alternate treatments, and the consequences of not having the surgery. Consent for surgery has become a critical component of surgical practice and is of increasing importance and must be updated with patient and legal expectations. For consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision. The principle of consent is an important part of medical ethics and international human rights law.
How do patients benefit from consent?
How do patients benefit from consent?
Robert Wheeler
The Bulletin, 30 September 2022; 104(7) pp 364-365
Abstract
Our legal contributor discusses how gaining consent for treatment, and the importance of discussing all alternatives available to a patient, is vital to maintaining good practice.
Editor’s note: The Bulletin is published by the Royal College of Surgeons of England.
The process of gaining consent, retrospectively, when the institution has closed down
The process of gaining consent, retrospectively, when the institution has closed down
Research Article
Lida Anagnostaki
Journal of Child Psychotherapy, 17 October 2022
Abstract
The paper has a twofold aim. First, it describes the complex process of gaining consent retrospectively for the publication of clinical material after the institution, where therapy was taking place, had closed down. The clinical material was derived from the psychotherapeutic work with an autistic young boy and his family. Details of the complicated process of gaining consent to publish this material are provided. The second aim of this paper is to discuss the important role of ‘trust’ when asking or granting consent for publication of clinical material. It is argued that trust at different levels (and amongst various people) plays a pivotal role in gaining consent for publication.
Is the Current Informed Consent Model Flawed?
Is the Current Informed Consent Model Flawed?
Book Chapter
Bert Heinrichs, Serap Ergin Aslan
Integrity of Scientific Research, 14 October; pp 549–557 [Springer]
Abstract
Informed consent is a widely acknowledged ethical principle that plays a crucial role, both in research ethics and medical ethics. However, empirical findings as well as theoretical considerations suggest that the current model of informed consent might be flawed. In particular, the understanding of information disclosed to patients and research participants during the consent process proves to be limited. This, in turn, casts serious doubt on the validity of the consent. In this paper, we will review the current state of research on informed consent and discuss the charge of inadequacy. Subsequently, we will examine some suggestions that have been presented in the literature to improve the current model of informed consent. At the end, we will summarize the current state of the discussion and give a brief outlook on future developments.
The Ethics of Advocacy and Consent
The Ethics of Advocacy and Consent
Book Chapter
Jill Pluquailec
Dis/orientating Autism, Childhood, and Dis/ability, 13 October 2022; pp 103–121 [Springer]
Abstract
This chapter, though short, is presented discretely between the end of the methodology chapter and before the analytical chapters because it is both methodological and analytical. It explores ethical issues, particularly in relation to advocacy and consent, which were necessary in developing, delivering and writing an ethical project. At the heart of the project is a queering of normative conceptualisations of autistic childhood which, as has already been discussed, requires a queering of traditional, theoretical and methodological orientations.
Editor’s note: Chapter bibliography available at title link above.
Autonomy and Liberty: An Ethical Focus on Human Consent
Autonomy and Liberty: An Ethical Focus on Human Consent
Jenia Kakchingtabam
International Journal of Arts Humanities & Social Sciences, 8 October 2022
Abstract
This paper aims to examine the problematic relation between autonomy and liberty from the ethical aspect of human consent. The term consent is derived from the Latin conjunction where “con” mean ‘together’ with “sentire” meaning to ‘feel’, ‘think’ or ‘judge’. We feel safe and secure when we participate in the collective life consensually. This idea of protection is provided by the liberal tradition thereby bringing a new complex form of human relation on the basis of consent and informed life. In fact, this new complex relation claims to provide us the benefit of protection from harms and constraints. Autonomy, on the other, indicates self-ruling capacities of a person to make certain plans or goals wherein the significance of consent protects from external wrongful coercion. And, here the question is, how can we discover the significance of autonomous consent of an individual within the sphere of liberty? This paper discusses the ethical issue of consent that seems to be interwoven in the concept of liberty and autonomy in three different sections. The first section examines the question that how and why consent occupies an important place in the social and the political relations of human beings? Further, the second section argues that the meaning of consent is not implied only in the sphere of social and political relation. Consent expresses a person’s sensitivity and experiences by allowing others to perceive the importance of human autonomy across the different areas of life. And, the third section addresses the crucial ethical crux of consent from the aspect of care and concern.
Informed Consent: A Monthly Review
_________________
October 2022 :: Issue 46
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_October 2022
Publication ethics: Patient consent for publishing case reports of adverse drug reactions is important yet absent from several recent manuscripts
Publication ethics: Patient consent for publishing case reports of adverse drug reactions is important yet absent from several recent manuscripts
A. Kumar
Ethics, Medicine and Public Health, October 2022; 24
Summary
Background
Case reports of adverse drug reactions (ADRs) constitute an important source of medication safety information. Detailed description of patients in such reports could potentially make subjects identifiable, thereby emphasizing the importance of consent for publication. The Committee on Publication Ethics and the International Committee of Medical Journal Editors recommend obtaining patient consent prior to publishing potentially identifiable patient information. However, this report shows absence of information regarding patient consent for publication from several recently-published ADR case reports.
Methodology
A sample of 100 most-recent ADR case reports with free full-text indexed in PubMed was qualitatively reviewed for information regarding publication consent and other ethical disclosures.
Results
Of the 100 most-recently-published ADR case reports, only 52 (52%) manuscripts clearly described obtaining patient consent for publication. Thirty-seven (37%) manuscripts made no mention of such consent or approval from an ethics committee. Eleven (11%) manuscripts contained ethical disclosures such as patient consent to undergo treatment and study approval from an institutional ethics committee, but without a clear statement regarding patient consent for publication.
Conclusion
A significant number of recently-published ADR case reports do not clearly describe if patient consent for publication was obtained. This could be attributable to various factors, including lack of clarity in journals’ guidelines regarding publication consent for case reports and dilemma regarding what constitutes identifiable patient information. This report calls for diligence of all stakeholders involved in medical manuscript publishing, viz. authors, manuscript reviewers, editors, and journal publishers to ensure that information regarding patient consent for publication is properly disclosed in ADR case reports.
Consensus on informed consent for participants in cancer clinical studies
Consensus on informed consent for participants in cancer clinical studies
Dawei Wu, Meimei Chen, Jing Liang, Shuang Li, Weijing Zhang, Yu Lei, Jing Ding, Yumeng Wang, Zhen Chen, Ning Li, Suxia Luo, Jie Li, Minghuang Hong, Zhao Yan
Asia-Pacific Journal of Oncology Nursing, 15 September 2022
Abstract
To fully protect the rights of participants in cancer clinical studies and clarify the key points for the ethics review of the content of informed consent forms and the process of collecting informed consent, the Medical Ethics Professional Committee of the China Anti-Cancer Association engaged in joint discussions with the ethics committees of well-known cancer hospitals in China to formulate this consensus, along with the attached general template for informed consent forms for cancer clinical studies. This work is expected to provide guidance and suggestions for the practice of the sponsors, researchers, and ethics committees.
Center for Informed Consent Integrity 