Patients’ views on laparoscopic cholecystectomy consent process: Consent in clinic improves quality of informed consent and patient satisfaction
Peiming Yang
British Journal of Surgery, 9 August 2022; 109(Supplement 5)
Abstract
Aims
Informed consent for elective laparoscopic cholecystectomy should begin at first clinic consultation. Due to clinic time pressures, informed consent is often obtained on the morning of surgery for the first time. This study aims to assess whether consent quality and patients’ consent satisfaction are better in clinic compared to day of surgery.
Methods
Retrospective review of all elective laparoscopic surgeries between April and June 2021. Self-administered questionnaire was also completed by the same cohort to ascertain consent satisfaction.
Results
38 patients in total during study period. 16(42.1%) were consented in clinic, and 22 were first consented on day of surgery. 25/38(65.8%) patients prefer to be consented in clinic, 13(34.2%) prefer consent on day of surgery. Significantly higher proportion of consent forms from clinic had full documentation of risks and benefits of cholecystectomy (P<0.001) compared to consents from day of surgery. Significantly higher proportion of patients consented in clinic felt adequately informed of procedure, had alternative options explained to them, were informed regarding recovery process, and felt there was adequate time for consent (P<0.05). Insignificantly higher proportion of patients consented in clinic received information leaflet about procedure. Overall consent satisfaction was significantly higher in patients consented in clinic (77% versus 55%, P=0.048%)
Conclusions
Consent quality and patient satisfaction levels for elective cholecystectomy were statistically significantly higher when consent was carried out in clinic prior to surgery compared to on the day of surgery. We recommend that all elective cholecystectomy consent is performed formally in clinic prior to surgery.
Year: 2022
Development of a core outcome set for informed consent for therapy: An international key stakeholder consensus study
Development of a core outcome set for informed consent for therapy: An international key stakeholder consensus study
Research
Liam J. Convie, Joshua M. Clements, Scott McCain, Jeffrey Campbell, Stephen J. Kirk, Mike Clarke
BMC Medical Ethics, 9 August 2022; 23(79)
Open Access
Abstract
Background
300 million operations and procedures are performed annually across the world, all of which require a patient’s informed consent. No standardised measure of the consent process exists in current clinical practice. We aimed to define a core outcome set for informed consent for therapy.
Methods
The core outcome set was developed in accordance with a predefined research protocol and the Core OutcoMes in Effectiveness Trials (COMET) methodology comprising systematic review, qualitative semi structured interviews, a modified Delphi process and consensus webinars to ratify outcomes for inclusion in the final core outcome set. (Registration—https://www.comet-initiative.org/Studies/Details/1024). Participants from all key stakeholder groups took part in the process, including patients and the public, healthcare practitioners and consent researchers.
Results
36 outcome domains were synthesised through systematic review and organised into a consent taxonomy. 41 semi-structured interviews were performed with all consent stakeholders groups. 164 participants from all stakeholder groups across 8 countries completed Delphi Round 1 and 125 completed Round 2. 11 outcomes met the ‘consensus in’ criteria. 6 met ‘consensus in’ all stakeholder groups and were included directly in the final core outcome set. 5 remaining outcomes meeting ‘consensus in’ were ratified over two consensus webinars. 9 core outcomes were included in the final core outcome set: Satisfaction with the quality and amount of information, Patient feeling that there was a choice, Patient feeling that the decision to consent was their own, Confidence in the decision made, Satisfaction with communication, Trust in the clinician, Patient satisfaction with the consent process, Patient rated adequacy of time and opportunity to ask questions.
Conclusion
This international mixed-methods qualitative study is the first of its kind to define a core outcome set for informed consent for intervention. It defines what outcomes are of importance to key stakeholders in the consent process and is a forward step towards standardising future consent research.
Informed Consent Practices in Global Surgery among Plastic Surgery Organizations
Informed Consent Practices in Global Surgery among Plastic Surgery Organizations
Special Topic
Kishan Thadikonda, Rosaline Zhang, Jonathan Bruhn, Phuong D. Nguyen, Samuel O. Poore
Plastic and Reconstructive Surgery, 8 August 2022
Abstract
Background
Global surgery organizations often serve vulnerable and complex patient populations, but there is limited knowledge on the protocols used to obtain informed consent for procedures and content sharing.
Methods
The Plastic Surgery Foundation Volunteers in Plastic Surgery (VIPS) database was queried for organizations actively involved in global surgery. Seventy-nine organizations received email invitations to participate in a survey study regarding their protocols for obtaining consent for procedures and sharing multimedia content.
Results
A total of 17 (22% yield) organizations completed the survey. All were active for at least 10 years and 88% (15/17) organized at least two mission trips annually. Eighty-eight percent (15/17) reported obtaining written consent for surgical procedures. Less than half (46%, 8/17) of used a written consent form that was created jointly with the local hospital. For sharing content related to global surgery experiences, 75% (12/16) obtained some form of written consent while 6% (1/16) did not routinely obtain any consent. Organizations shared content most commonly through their websites and Facebook. All organizations reported using interpreters to obtain informed consent at least some of the time. 62% (10/16) reported that they relied primarily on volunteers or community members to provide informal interpretation assistance, rather than formally trained professional interpreters.
Conclusion
Practices related to obtaining informed consent vary widely among global surgery organizations. The development of standardized protocols and guidelines will ensure that global health organizations, in collaboration with their local partners, properly obtain informed consent for procedures and sharing publicly viewable content.
Are we meeting the standards set for informed consent in spinal surgery?
Are we meeting the standards set for informed consent in spinal surgery?
Y Esemen, A Mostofi, D Richardson, EAC Pereira
Annals of Royal College of Surgeons, 29 July 2022
Abstract
Introduction
Informed consent empowers patients to exercise their autonomy and actively participate in their medical care. Guidance published by the British Association of Spine Surgeons (BASS) lists three components of consent: provision of information booklets, patient-centred dialogue and completion of appropriate consent forms. The aim of the study was to review the quality of the spinal surgery consent process against the BASS guidance in a single tertiary neurosurgery centre in London.
Methods
Retrospective review of clinic letters and consent forms was performed for 100 consecutive cases of elective, non-instrumented spinal decompression surgeries performed in 2019. Documentation was graded for inclusion of the intended benefit (improvement of pain/prevention of neurological deterioration), alternative management options (including no treatment), surgical options and risks (infection, bleeding, paralysis, sphincter disturbances, dural tear and recurrence). Provision of supplementary information booklets was recorded. Two-tailed Fisher exact test was used to calculate statistical significance where appropriate.
Results
Documentation of indications and risks of elective spinal surgery, specifically risk of recurrence (62%) and sphincter disturbance (85%), was suboptimal on the consent forms. Documentation of these risks was also poor in clinic letters (<50%). Alternative treatment options were explained in less than half of the clinic letters, and there was no documentation of information booklet provision prior to elective surgeries.
Conclusion
Lack of informed consent plays a major role in medical malpractice claims in spinal surgery. Poor documentation puts the surgeon in a liable position. BASS guidance could be implemented to create a more standardised process of consent in spinal surgery.
“What are my options?”: Physicians as ontological decision architects in surgical informed consent
“What are my options?”: Physicians as ontological decision architects in surgical informed consent
Original Article
Stacy S. Chen, Sunit Das
Bioethics, 1 August 2022
Abstract
The aim of a theoretically ideal process of informed consent is to promote the autonomy of the patient and to limit unethical physician paternalism. However, in practice, the nature of the medical profession requires physicians to act as ontological decision architects—based on the medical knowledge that they acquire through their experience and training, physicians ontologically determine a subset of viable courses of action for their patient. What is observed is not an unethical physician limitation or biasing of the patient towards certain treatment options that violates patient autonomy or consciously undermines informed consent, but rather a more foundational paternalism that is necessarily inherent to the physician–patient relationship. In this article we argue for a recognition of this underlying physician paternalism and posit that this necessary paternalism is not a foil to patient autonomy, but rather a foundational aspect of the duties of the medical professional within the physician–patient relationship.
Consent — Informed Consent and Requirements of Consent
Consent — Informed Consent and Requirements of Consent
Book
Kumari K. Nirmala
Health Laws in India, 2022 [Routledge]
Abstract
In the medical treatment, the relationship between the doctor and the patient has been in terms of benevolent paternalism. In ancient times, the obligation of the physician was solely in terms of promoting the welfare of the patient, diagnosing the ailment, and prescribing medicine or surgery, but seldom had they thought about patient’s right. But nowadays this locus of the authority in decision making has been shifted from the physician to the patient. A patient will receive all the information that he or she needs in order to make decision as to take treatment or not or a particular operation. There involves the consent of the patient. Consent to treatment is the principle that a person must give permission before they receive any type of medical treatment, test or examination. This must be done on the basis of an explanation by a clinician. Consent from a patient is needed regardless of the procedure, whether it a physical examination, organ donation or something else. The principle of consent is an important part of medical ethics and the international human rights law.
80 The earliest expression of this fundamental principle, based on autonomy, is found in the Nuremberg Code of 1947. The code makes it mandatory to obtain voluntary and informed consent of human subjects. Similarly, the Declaration of Helsinki adopted by the World Medical Association in 1964 emphasizes the importance of obtaining freely given informed consent for medical research by adequately informing the subjects of the aims, methods, anticipated benefits, potential hazards, and discomforts that the study may entail. Several international conventions and declarations have similarly ratified the importance of obtaining consent from patients before testing and treatment.
In India the principle of autonomy is enshrined within Art. 21 of the Indian Constitution, which deals with the right to life and personal liberty. Sec 88 of IPC, provides- Nothing which is not intended to cause death, is an offence to any person for whose benefit it is done in good faith, and who has given a consent. When a tort is committed, meaning that a defendant’s actions interfered with the plaintiff’s person or property, a plaintiff’s consent will excuse the defendant of the wrongdoing.
In the view of the above background, the present chapter proposes to deal briefly with the aspects of laws concerning consent in medical cases, and their implications. The chapter discusses about the capacity to give consent, ‘Real’ consent in the United Kingdom (UK) and as ‘Informed’ consent in the United States (US). To account for the Indian position, unlike in the West, the courts have assigned immense significance to the requirement of informed consent. The Honorable Court has in different cases summarized principles relating to consent and the necessity to enact full-fledged laws so as to adjust to the need of the day.
Informed Consent: A Monthly Review
_________________
August 2022
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_August 2022
The patient suffering from acute respiratory failure COVID-19 related who refuses medical treatment: an emblematic case
The patient suffering from acute respiratory failure COVID-19 related who refuses medical treatment: an emblematic case
Francesca Maghin, Massimo Salvetti, Maria Lorenza Muiesan, Adelaide Conti
Internal and Emergency Medicine, 2 July 2022
Open Access
Abstract
Respiratory failure related to COVID-19 may evolve into acute respiratory distress syndrome, which may require invasive treatment. Through the analysis of a concrete clinical case, we want to clarify how to manage patients suffering from serious acute pathologies, which require timely intervention, even invasive, but refuse medical treatment. The Italian law 219/2017 states strongly the freedom of the patient to choose, independently whether to start or stop at any time any type of medical treatment through their informed consent. The law, of course, addresses in several parts the problem of the refusal of the subject to certain choices. The law also provides that if the patient refuses therapies or interventions, putting his life at risk, the doctors need to engage in further communication with the support of other professionals, informing the patient of the consequences, promoting every support action, and involving family members. Judgment on the level of impaired capacity, which makes a patient incompetent to make therapeutic decisions, should ideally reflect the balance between respecting patient autonomy and protecting the patient from the consequences of a wrong decision. For the physicians, it is a matter of balancing the need to save the life of the person, or at least to avoid the establishment of permanent damage, with the subject itself expressly stated, including an explicit refusal to carry out maneuvers or therapies or interventions when it is in danger of life, even if such treatments could save it.
Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions
Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions
Julie R Bromberg, Evelyn Nimaja, Andrew W Kiragu, Karla A Lawson, Lois Lee, Isam W Nasr, Charles Pruitt, Stephanie M Ruest, Michael J Mello
Ethics and Human Research, July 2022; 44(4) pp 39-44
Abstract
The Covid-19 pandemic resulted in unprecedented restrictions on many public, private, and workplace activities throughout the United States and elsewhere. When restrictions were imposed, we were conducting a type III hybrid effectiveness-implementation trial in 10 pediatric trauma centers. In response to several pandemic-based restrictions, we had to develop procedures for engaging with potential research participants while limiting nonclinical, in-person interactions. This manuscript describes the procedures and challenges of obtaining electronic informed consent and assent in a multisite trauma center-based research study. We developed, tested, and trained staff to implement three options for obtaining informed consent. Twenty-five participants were enrolled in the effectiveness-implementation multisite trial during the first six months of utilization of the consent options, with eleven of these individuals enrolled using hybrid or electronic consent procedures. The challenges we identified involving electronic consent procedures included confusion over who would complete the electronic consent process and difficulties reconnecting with families. Lessons learned can strengthen electronic consent and assent procedures for future studies. More research is needed to further strengthen this process and increase its utilization.
A mother’s perspective of consent for maternal and neonatal COVID-19 testing: can we do more?
A mother’s perspective of consent for maternal and neonatal COVID-19 testing: can we do more?
Research
Natalie Anne East, Sunitha Ramaiah, Kimberley Morris, Sangeeta Pathak
British Journal of Midwifery, 28 June 2022; 30(7)
Abstract
Background
There is ongoing research on the effects of COVID-19 on pregnancy and whether vertical viral transmission occurs.
Aims
This study aimed to determine maternal opinions of COVID-19 testing for pregnant women and newborns in order to influence future clinical practice while advancing global knowledge of the impact of testing on patient experiences.
Methods
This service evaluation assessed the opinions of 292 pregnant women who were tested for COVID-19 along with their newborn babies using nasopharyngeal swabs and the SARS-CoV-2 reverse transcription polymerase chain reaction test between 28 April and 21 May 2020.
Results
Many women felt their own (60%) and their baby’s (61%) swab was compulsory and did not feel sufficiently informed about the risks and benefits for themselves (43%) or their baby (52%) being tested. Some women did not understand the implications of a positive test for themselves (43%) or their baby (42%). Most participants reported they would agree to themselves (97%) and their baby (86%) being tested in future pregnancies.
Conclusion
Communication to pregnant women regarding the COVID-19 swabbing process is critical and requires improvement. This service evaluation highlighted where women felt under-informed. These areas should be covered in more detail for consenting women for COVID-19 testing in future.
Center for Informed Consent Integrity 