Using a chat-based informed consent tool in large-scale genomic research
Sarah K Savage, Jonathan LoTempio, Erica D Smith, E Hallie Andrew, Gloria Mas, Amanda H Kahn-Kirby, Emmanuèle Délot, Andrea J Cohen, Georgia Pitsava, Robert Nussbaum, Vincent A Fusaro, Seth Berger, Eric Vilain
Journal of the American Medical Informatics Association, 4 September 2023
Abstract
Objective
We implemented a chatbot consent tool to shift the time burden from study staff in support of a national genomics research study.
Materials and Methods
We created an Institutional Review Board-approved script for automated chat-based consent. We compared data from prospective participants who used the tool or had traditional consent conversations with study staff.
Results
Chat-based consent, completed on a user’s schedule, was shorter than the traditional conversation. This did not lead to a significant change in affirmative consents. Within affirmative consents and declines, more prospective participants completed the chat-based process. A quiz to assess chat-based consent user understanding had a high pass rate with no reported negative experiences.
Conclusion
Our report shows that a structured script can convey important information while realizing the benefits of automation and burden shifting. Analysis suggests that it may be advantageous to use chatbots to scale this rate-limiting step in large research projects.
Month: September 2023
Counseling, informed consent, and debriefing for cesarean section in sub-Saharan Africa: A scoping review
Counseling, informed consent, and debriefing for cesarean section in sub-Saharan Africa: A scoping review
Faysal S, Penn-Kekana L, Day LT, Tripathi V, Khan F, Stafford R, Levin K, Campbell O, Filippi V
International Journal of Gynaecology and Obstetrics, 12 September 2023
Abstract
Background
Counseling as part of the informed consent process is a prerequisite for cesarean section (CS). Postnatal debriefing allows women to explore their CS with their healthcare providers (HCPs).
Objectives
To describe the practices and experiences of counseling and debriefing, the barriers and facilitators to informed consent for CS; and to document the effectiveness of the interventions used to improve informed consent found in the peer-reviewed literature.
Search strategy
The databases searched were PubMed, EMBASE, PsycINFO, Africa-wide information, African Index Medicus, IMSEAR and LILACS.
Selection criteria
English-language papers focusing on consent for CS, published between 2011 and 2022, and assessed to be of medium to
high quality were included.
Data collection and analysis
A narrative synthesis was conducted using Beauchamp and Childress’s elements of informed consent as a framework.
Main results
Among the 21 included studies reporting on consent for CS, 12 papers reported on counseling for CS, while only one reported on debriefing. Barriers were identified at the service, woman, provider, and societal levels. Facilitators all operated at the provider level and interventions operated at the service or provider levels.
Conclusions
There is a paucity of research on informed consent, counseling, and debriefing for CS in sub-Saharan Africa.
Informed Consent and Ethical Considerations in Assisted Reproductive Technology in Nigeria: Options and Challenges
Informed Consent and Ethical Considerations in Assisted Reproductive Technology in Nigeria: Options and Challenges
Book Chapter
Folakemi O. Ajagunna
Reproductive Health and Assisted Reproductive Technologies In Sub-Saharan Africa, 29 August 2023 [Springer]
Abstract
Informed consent, permission given by a patient in full knowledge of the consequences, risks or potential benefits of the medical procedure to be carried out is a sine qua non in the practice of Assisted Reproductive Technologies. This permission emanates from the right to autonomy which a patient should enjoy. Implicit within this right to informed consent is that the patient is given adequate information about the treatment he or she is to be subject to. Where informed consent is not obtained, it could result in jeopardy for both the medical practitioner and the patient. This chapter examines issues emanating from informed consent in assisted reproduction in Nigeria. It adopts a socio-legal approach to interrogate the practice of informed consent in Nigeria. In-depth and key-informant interviews were conducted with IVF doctors, embryologists and women patronising IVF clinics to ascertain practices in various IVF clinics in Nigeria. The research found that although there are guidelines on informed consent in the rules of professional conduct in Nigeria, this is not a true reflection of what obtains in the ART industry. The research recommends that in addition to the rules or ethos of the medical profession in Nigeria, a legal framework is essential to advance the rights of patients to full and adequate information in assisted reproduction.
Principles of consent in trauma and orthopaedics
Principles of consent in trauma and orthopaedics
Christopher Wilson, Qamar Mustafa, Tim Crook
Surgery (Oxford), 9 September 2023
Abstract
Consent is one of the essential elements of daily practice for clinicians working in Trauma and Orthopaedics. Autonomy is the right of competent adults to make informed decisions about their care. GMC guidance has placed a professional burden on surgeons to provide informed decision making. The Montgomery v Lanarkshire Health Board (2015) case set a precedent that has driven the modernization of consenting practice, raising the status of shared decision making from guidance to legal requirement. In a post-Montgomery landscape, consent is often the first focus for lawyers and insurers when medico-legal malpractice suit is concerned. Orthopaedic surgeons are at a higher risk of facing malpractice suites (Gould et al., 2003), yet there is a lack of formal training regarding obtaining and documenting informed consent. In this article we discuss the historical context, the current status of consent within UK medical practice, as well as strategies to ensure that consent is legally obtained within Trauma and Orthopaedics.
General Preoperative Workup, Informed Consent, Antibiotic Prophylaxis, and Anesthesia in Thyroid Surgery
General Preoperative Workup, Informed Consent, Antibiotic Prophylaxis, and Anesthesia in Thyroid Surgery
Book Chapter
Angela Gurrado, Lucia Ilaria Sgaramella, Elisabetta Poli, Walter Lavermicocca, Antonella Filoia, Mario Testini
Thyroid Surgery, 18 September 2023 [Springer]
Open Access
Abstract
Thyroidectomy is the treatment of choice for benign and malignant thyroid disease. The diagnostic workup has to define the thyroid disease, the therapeutic strategy, and the extension of the potential surgery. Providing patient education is a fundamental step in the surgeon-patient relationship and it is performed before any medical-surgical intervention with the aim of enabling the patient’s conscious self-determination. Patients should be adequately informed by the surgeon about the indications for surgery, alternative treatments, complications and possible permanent consequences. Thyroid surgery is considered a clean procedure, and hence antibiotic prophylaxis should not be routinely employed except under specific conditions. Anesthesia for thyroid surgery requires an experienced team in the recognition, assessment, and management of a potentially difficult airway, in a patient who may also have significant comorbidity. Neuromonitoring is effective for identifying and monitoring the function of the laryngeal nerves. The anesthetist is actively involved in this procedure, in particular as concerns correct positioning of the endotracheal tube and management of the neuromuscular blockade.
Issues of informed consent for non-specialists conducting colorectal cancer screenings
Issues of informed consent for non-specialists conducting colorectal cancer screenings
Forrest Bohler, Allison Garden
Journal Of Osteopathic Medicine, 12 September 2023
Abstract
The United States is currently facing a physician shortage crisis including a lack of specialist providers. Due to this shortage of specialists, some primary care providers offer colorectal cancer screenings in communities with few gastroenterologists, especially in under-resourced areas such as rural regions of the United States. However, discrepancies in training and procedural outcomes raise concerns regarding informed consent for patients. Because osteopathic physicians play a critical role in addressing the physician shortage in these under-resourced communities, this commentary may be especially useful because they are likely to encounter these ethical complexities in their day-to-day practice.
Informed consent for total knee arthroplasty: exploration of patient`s information acquisition and decision-making processes—a qualitative study
Informed consent for total knee arthroplasty: exploration of patient`s information acquisition and decision-making processes—a qualitative study
Research Article
Sandro Zacher, Julia Lauberger, Carolin Thiel, Julia Lühnen, Anke Steckelberg
BMC Health Services, 11 September 2023; 23(978)
Open Access
Abstract
Background
Total knee arthroplasty (TKA) is an option for the treatment of knee osteoarthritis (OA). Patients have high expectations regarding the benefits of the actual operation. Patients can seek a second opinion on the indication for TKA. In a study, less than half of recommended TKAs were confirmed by the second opinion and conservative treatments are not fully utilized. Informed consent forms that are used in Germany usually do not meet the requirements to support informed decision-making. Our aim was to describe the process from the diagnosis of knee OA through the decision-making process to the informed consent process for TKA, and to understand when, how, and by whom decisions are made. Moreover, we wanted to describe patients’ information needs and preferences about knee OA and its treatment, including TKA, and find out what information is provided. We also wanted to find out what information was important for decision-making and identify barriers and facilitators for the optimal use of evidence-based informed consent forms in practice.
Methods
We chose a qualitative approach and conducted semi-structured interviews with patients who were going to receive, have received, or have declined TKA, and with general practitioners (GP), office-based as well as orthopaedists and anaesthesiologists in clinics who obtain informed consent. The interviews were audio-recorded, transcribed and analysed using qualitative content analysis.
Results
We conducted interviews with 13 patients, three GPs, four office-based orthopaedists and seven doctors in clinics who had obtained informed consent. Information needs were modelled on subjective disease theory and information conveyed by the doctors. Patients in this sample predominantly made their decisions without having received sufficient information. Trust in doctors and experiences seemed to be more relevant in this sample than fact-based information. Office-based (GPs, orthopaedists) and orthopaedists in clinics had different understandings of their roles and expectations in terms of providing information.
Conclusions
We were able to identify structural barriers and assumptions that hinder the implementation of evidence-based informed consent forms.
Optimizing Informed Consent Discussions: Developing a Narrative for Transfusion Consent
Optimizing Informed Consent Discussions: Developing a Narrative for Transfusion Consent
Michelle P. Zeller, Marissa Laureano, Aditi Khandelwal, Shannon J. Lane, Richard Haspel, Mark Fung
Transfusion Medicine Reviews, 9 September 2023
Abstract
Ensuring patient informed consent is a key tenet of modern medicine. Although transfusion of blood products is among the most common medical procedures performed in hospitalized patients, there is evidence that informed consent for transfusion is at times incomplete, poorly understood, hurried and/or inaccurate. This study aimed to develop a narrative that can be used as a framework for practicing physicians and for educational purposes to optimize the process for obtaining informed consent for blood transfusion.
The narrative was developed using a modified-Delphi approach with 5 Rounds that included feedback from Transfusion Medicine (TM) experts, transfusion-provider physicians and lay people. The surveys collected qualitative and quantitative data analyzed using thematic content analysis and descriptive statistics, respectively. Results from Round 1 and 2 generated a draft narrative and rounds 3 to 5 informed further modifications.
Round 1 included draft narrative scripts from 28 TM experts; thematic coding generated 97 topics. In round 2, 22/28 of the initial experts rated items identified from Round 1. Those with a Content Validity Index (CVI) ≥ 0.8 were used by the authors to develop a narrative. In Round 3, 20/24 participants from Round 2 reviewed the narrative with 100% agreeing on the items included and 90% agreeing the flow was logical. In Round 4, 23 transfusion prescribers (non-TM physicians) reviewed the narrative for flow, manner, length and usability; there was 83% agreement with non-exclusion of important topics; 91% felt it would be effective for teaching trainees. Round 5 included 24 non-medical lay people of different demographics. Most participants (92%) thought that the script was appropriate in length and there were opportunities to ask questions. Participants could also identify the adverse transfusion reactions and understood that they could refuse the transfusion. A narrative for obtaining informed consent for blood transfusion was created through multiple rigorous iterations of review and feedback with both transfusion providers and the lay public. The narrative, developed for a specific clinical scenario, was well-received by medical and non-medical participants and can be used, and modified, to help ensure patients understand the risks and benefits of blood transfusion.
Minimum standard assessment of informed consent for internal medicine transition to residency program: A cohort study
Minimum standard assessment of informed consent for internal medicine transition to residency program: A cohort study
Mannat Marwaha, Raman Bhalla, Shivani Rao, Catherine Chen
Health Science Reports, 10 August 2023
Abstract
Background and Aims
Interns must be proficient in obtaining informed consent (IC), which is the Association of American Medical College’s 11th of 13 Entrustable Professional Activities (EPAs). Medical students have limited opportunity to practice IC during clerkships, resulting in inconsistent proficiency. We aimed to create a tool to assess whether our transition to residency (TTR) workshop enables fourth‐year medical students to meet a minimum standard of obtaining IC.
Methods
Sixty fourth‐year medical students were enrolled in the internal medicine virtual TTR course during AY2021. The curriculum prioritizes deliberate practice activities. Pre‐ and postworkshop assignments involved students typing verbatim what they would say during IC encounters. We modified an IC abstraction tool created by Spatz et al. to assess a minimum standard for students’ IC assignments. Our final 7‐item tool consisted of the following domains: “What,” “Why,” “How,” “Benefits,” “Quantitative Risks,” “Qualitative Risks,” and “Alternatives,” weighing 1 point each. A minimum standard was obtained with a score of 6 or more points by appropriately discussing at least one domain involving risk and all other domains.
Results
Students scored highly on the prework domains pertaining to “What,” “Why,” and “How” of the procedure with no significant difference on postwork. Significant improvement was achieved on postwork domains covering “Benefits” (p = 0.039) and “Alternatives” (p = 0.031). For domains involving “Qualitative” and “Quantitative Risks,” there were no statistically significant improvements from pre‐ to postwork scores. Fifteen and 22 students met the minimum standard for IC on pre‐ and postwork, respectively.
Conclusion
Our students demonstrated a good a priori understanding of the “What,” “Why,” and “How” domains. After the workshop, they more reliably discussed “Benefits” and “Alternatives.” Our abstraction tool helped assess the strengths and weaknesses in our students’ IC skillset and helped recognize areas of our curriculum that will benefit from improvements to bring students to meet the minimum standard.
A troubling foundational inconsistency: autonomy and collective agency in critical care decision-making
A troubling foundational inconsistency: autonomy and collective agency in critical care decision-making
Stowe Locke Teti
Theoretical Medicine and Bioethics, 28 March 2023; 44 pp 279–300
Abstract
‘Shared’ decision-making is heralded as the gold standard of how medical decisions should be reached, yet how does one ‘share’ a decision when any attempt to do so will undermine autonomous decision-making? And what exactly is being shared? While some authors have described parallels in literature, philosophical examination of shared agency remains largely uninvestigated as an explanation in bioethics. In the following, shared decision-making will be explained as occurring when a group, generally comprised of a patient and or their family, and the medical team become a genuine intentional subject which acts as a collective agent. Collective agency can better explain how some medical decisions are reached, contrary to the traditional understanding and operationalization of ‘autonomy’ in bioethics. Paradoxically, this often occurs in the setting of high-stakes moral decision-making, where conventional wisdom would suggest individuals would most want to exercise autonomous action according to their personally held values and beliefs. This explication of shared decision-making suggests a social ontology ought to inform or displace significant aspects of autonomy as construed in bioethics. It will be argued that joint commitments are a fundamental part of human life, informing and explaining much human behavior, and thus suggesting that autonomy – conceived of as discrete, individuated moral reasoning of a singular moral agent – is not an unalloyed ‘good.’