Multicomponent Informed Consent with Marshallese Participants
Research Article
Rachel S. Purvis, Britni L. Ayers, Cari A. Bogulski, Kyle F. Kaminicki, Lauren K. Haggard-Duff, Lynda A. Riklon, Anita Iban, Rotha Mejbon-Samuel, Rumina Lakmis, Sheldon Riklon, Joseph W. Thompson, Pearl A. McElfish
Journal of Empirical Research on Human Research Ethics, 29 March 2021
Abstract
Pacific Islanders are the second fastest-growing population in the United States; however, Pacific Islanders, and Marshallese specifically, are underrepresented in health research. A community-based participatory research (CBPR) approach was used to engage Marshallese stakeholders and build an academic-community research collaborative to conduct health disparities research. Our CBPR partnership pilot tested a multicomponent consent process that provides participants the option to control the use of their data. Consent forms used concise plain language to describe study information, including participant requirements, risks, and personal health information protections, and were available in both English and Marshallese. This study demonstrates that when provided a multicomponent consent, the vast majority of consenting study participants (89.6%) agreed to all additional options, and only five (10.4%) provided consent for some but not all options. Our description of the development and implementation of a multicomponent consent using a CBPR approach adds a specific example of community engagement and may be informative for other indigenous populations.
Informed Consent for Mobile Phone Health Surveys in Colombia: A Qualitative Study
Informed Consent for Mobile Phone Health Surveys in Colombia: A Qualitative Study
Research Article
Mariana Rodriguez-Patarroyo, Angelica Torres-Quintero, Andres I. Vecino-Ortiz, Kristina Hallez, Aixa Natalia Franco-Rodriguez, Eduardo A. Rueda Barrera, Stephanie Puerto, Dustin G. Gibson, Alain Labrique, George W. Pariyo, Joseph Ali
Journal of Empirical Research on Human Research Ethics, 25 September 2020
Abstract
Public health surveys deployed through automated mobile phone calls raise a set of ethical challenges, including succinctly communicating information necessary to obtain respondent informed consent. This study aimed to capture the perspectives of key stakeholders, both experts and community members, on consent processes and preferences for participation in automated mobile phone surveys (MPS) of non-communicable disease risk factors in Colombia. We conducted semi-structured interviews with ethics and digital health experts and focus group discussions with community representatives. There was meaningful disagreement within both groups regarding the necessity of consent, when the purpose of a survey is to contribute to the formulation of public policies. Respondents who favored consent emphasized that consent communications ought to promote understanding and voluntariness, and implicitly suggested that information disclosure conform to a reasonable person standard. Given the automated and unsolicited nature of the phone calls and concerns regarding fraud, trust building was emphasized as important, especially for national MPS deployment. Community sensitization campaigns that provide relevant contextual information (such as the name of the administering institution) were thought to support trust-building. Additional ways to achieve the goals of consent while building trust in automated MPS for disease surveillance should be evaluated in order to inform ethical and effective practice.
The use of bovine pericardial patches in vascular surgery: where do we draw the line in obtaining informed consent?
The use of bovine pericardial patches in vascular surgery: where do we draw the line in obtaining informed consent?
Stacie Hodge, Nicholas Greaves, David Murray
Annals of Vascular Surgery, 24 April 2021
Abstract
With advances in modern medicine there has been unprecedented growth in biological materials derived from either porcine or bovine products. Absolute or relative restrictions of the dietary consumption of bovine or porcine products among different religious groups are relatively well documented. However, there are no clear guidelines about the non-dietary use of animal products for patients with particular secular or religious beliefs. For a patient undergoing a carotid endarterectomy, induction with propofol, administration of heparin at the time of vessel clamping, use of a bovine pericardial patch for angioplasty, covering the wound with a hydrocolloid dressing and post-operative aspirin administration exposes the patient to animal products at every stage, from the moment they walk through the door. A number of articles have advocated obtaining informed consent when using animal products in healthcare but where should the line be drawn? In particular, should we consent for the use of bovine pericardium in vascular surgery? This paper reviews the evidence available and discusses our current standpoint from both a legal and ethical aspect.
Do we achieve the Montgomery standard for consent in orthopaedic surgery?
Do we achieve the Montgomery standard for consent in orthopaedic surgery?
Xenia N Tonge, Henry Crouch-Smith, Vijay Bhalaik, William D Harrison
British Journal of Hospital Medicine, 21 April 2021
Abstract
Aims/Background
The Montgomery v Lanarkshire Health Board (2015) case set a precedent that has driven the modernisation of consenting practice. Failure to demonstrate informed consent is a common source of litigation. This quality improvement project aimed to provide pragmatic guidance for surgeons on consent and to improve the patient experience during decision making.
Methods
Elective orthopaedic patients were assessed and the quality of documented consent was recorded. Data were collected over two discrete cycles, with cycle 1 used as a baseline in practice. The following criteria were reviewed: grade of consenting clinician, alternative treatment options, description of specific risks, place and timing of consent and whether the patient received written information or a copied clinic letter. Cycle 1 results were presented to clinicians; a teaching session was provided for clinicians on the standard of consent expected and implementation of a change in practice was established with a re-audit in cycle 2.
Results
There were 111 patients included in cycle 1, and 96 patients in cycle 2. Consent was undertaken mostly by consultants (54%). Specific patient risks were documented in 50% of patients in cycle 1 and 60% in cycle 2. Risks associated with a specific procedure were documented in 42% in cycle 1 and 76% in cycle 2, alternative options in 48% (cycle 1) and 66% (cycle 2). A total of 14% of patients in cycle 1 and 8% in cycle 2 had documented written information provision. Copied letters to patients was only seen in 12% of all cycles. Documentation from dedicated consenting clinics outperformed standard clinics.
Conclusions
Highlighting poor documentation habits and refining departmental education can lead to improvements in practice. The use of consenting clinics should be considered and clinicians should individually reflect on how to address their own shortcomings. Other units should strongly consider a similar audit. This article provides stepwise advice to improve consent and specifics from which to audit.
Informed consent in interventional radiology – are we doing enough?
Informed consent in interventional radiology – are we doing enough?
Akash Prashar, Saqib Butt, Davide Giuseppe Castiglione, Nadeem Shaida
British Journal of Radiology, 21 April 2021
Abstract
Objectives
Obtaining informed consent is a mandatory part of modern clinical practice. The aim of this study was to identify how often complications relating to Interventional Radiology (IR) procedures were discussed with the patient prior to the procedure.
Methods
A retrospective analysis of 100 patients who experienced a complication related to an IR procedure was performed. The patient’s procedure consent form was examined to identify whether the complication they experienced had been discussed as a possible risk. Other parts of the consent form relating to need for blood transfusion and the need for further procedures were also examined.
Results
39% of patients who experienced a complication did not have the complication documented as a potential risk on the consent form. 14% of patients required a blood transfusion but were not consented for this. 42% of patients required a further procedure or operation but were not warned of this.
Conclusion
The model of gaining informed consent on the day of procedure is no longer valid. Better education and the use of clinics, patient information sheets and other resources is essential.
Pre-Abortion Informed Consent Through Telemedicine vs. in Person: Differences in Patient Demographics and Visit Satisfaction
Pre-Abortion Informed Consent Through Telemedicine vs. in Person: Differences in Patient Demographics and Visit Satisfaction
Original Article
Shelly Kaller, Sara Daniel, Sarah Raifman, M. Antonia Biggs, Daniel Grossman
Women’s Health Issues, 5 April 2021
Abstract
Purpose
Utah law requires patients to have a face-to-face “informed consent” visit at least 72 hours prior to abortion. Planned Parenthood Association of Utah (PPAU) offers this visit via telemedicine as an alternative to an in-person visit, which can require burdensome travel. This novel study identifies factors associated with using telemedicine for informed consent, patients’ reasons for using it, and experiences with it, compared to in-person informed consent.
Methods
In 2017 and 2018, patients 18 years and older seeking abortion at PPAU completed a self-administered online survey about their experiences with the informed consent visit. We used linear and logistic regression models to compare participants’ demographic characteristics by informed consent visit type, and descriptive statistics to describe reasons for using each visit type and experiences with the visit. Multivariable logistic regression models examined associations between visit type and satisfaction.
Results
Responses from 166 telemedicine patients and 217 in-person informed consent patients indicate that telemedicine participants would have had to travel significantly further than in-person participants traveled to attend the visit at the clinic (mean of 65 miles versus 21 miles, p < .001). In multivariable analyses, telemedicine participants had higher odds of being “very satisfied” with the visit (aOR, 2,89; 95% CI: 1.93–4.32) and “very comfortable” asking questions during the visit (aOR, 3.76; 95% CI: 2.58–5.49), compared to participants who attended in-person visits.
Conclusions
Telemedicine offers a convenient, acceptable option for mandated pre-abortion informed consent visits and reduces the burden of additional travel and associated barriers for some patients, particularly those who live further away from clinics.
[In search of open minds and shared consent – Information, treatment options and postoperative care from the patient’s perspective]
[In search of open minds and shared consent – Information, treatment options and postoperative care from the patient’s perspective]
Ganz-Blättler U
Therapeutische Umschau. Revue Therapeutique, 1 April 2021; 78(3) pp 149-157
Abstract
This paper addresses knowledge gaps which are prone to handicap the ongoing communication process between medical / care personnel and patients of breast cancer, due to everyday routine and presumed lack of time. The respective qualitative studies do point to divergent expectations with regards to medical consultations and indicate that patients’ satisfaction with therapeutic measures, which were decided in advance, might be improved. Three exemplary aspects of doctor-patient communication are then looked at closer: first the variety of treatment options offered, second the risk of expressing unconscious bias regarding patients’ physical appearance and identity, and third the increasingly acknowledged desire of breast cancer patients to consult (… additionally, not alternatively) with other patients that are, or were previously affected by breast cancer and confronted with the decisions this condition entails.
Editor’s note: This is a German language publication.
Informed consent: What risks are material to patients consenting for urological procedures?
Informed consent: What risks are material to patients consenting for urological procedures?
Research Article
Nadine McCauley, Siya Lodhia, Andrea Ong, Calum Clark, Tim Lane
Journal of Clinical Urology, 31 March 2021
Abstract
Objective
This study aimed to assess patient recall of the consent discussion for urological procedures and to identify which risks were material to urology patients.
Methods
A total of 102 patients undergoing urological procedures were interviewed in the 24-hour period surrounding the procedure. A self-designed, piloted questionnaire recorded information from the patient’s signed consent form and patient-reported data of the consent discussion.
Results
The mean patient recall was 2.06 risks, whereas the average number of risks listed by the operating surgeon on the consent form was 5.69 risks. The most frequently recalled risk was impotence (91%), followed by urinary incontinence (63%) and haematuria (61%). The risks associated with poorest patient recall were stent symptoms (0%), urethral catheter insertion (5%) and recurrence (8%).
Conclusions
Poor patient recall of the consent discussion has again been demonstrated in this study. However, certain urological procedure risks are better recalled by patients, with impotence, urinary incontinence and haematuria being most frequently recalled. Medical terminology such as stent or catheter may be poorly recalled due to a disparity in understanding between patient and clinician. Clinicians should be aware of poor patient recall when consenting for urology procedures and should ensure precise documentation.
Harming one to benefit another: The paradox of autonomy and consent in maternity care
Harming one to benefit another: The paradox of autonomy and consent in maternity care
Original Article
Elselijn Kingma
Bioethics, 11 December 2020
Open Access
Abstract
This paper critically analyses ‘the paradox of autonomy and consent in maternity care’. It argues that maternity care has certain features that increase the need for explicit attention to, and respect for, both autonomy and rigorous informed consent processes. And, moreover, that the resulting need is considerably greater than in almost all other areas of medicine. These features are as follows: (1) maternity care involves particularly socially sensitive body parts that are regularly implicated in consent-centred procedures, as well as in unconsented interventions, in ordinary, non-medical life; and (2) much of maternity care (especially intervening in childbirth) is medically unique, in that it harms one patient (the mother) not primarily for the promotion of her own health but for the benefit of another (the baby). The apt comparison, within medicine, is therefore with non therapeutic research and transplantation medicine—both of which have elevated consent requirements characterized by very rigorous consent processes. At the same time—and this delivers the titular paradox—the importance of autonomy and consent in maternity care is at particular risk of being denied or disregarded. Jointly, these considerations make a very strong case for change: attention to and respect for autonomy and consent should be (1) core values; (2) key points of practical attention in the years ahead; and (3) central quality indicators in maternity care.
Medical images, social media and consent
Medical images, social media and consent
Comment
Jonathan P. Segal, Richard Hansen
Nature Reviews Gastroenterology & Hepatology, 23 April 2021
Excerpt
The popularity of social media amongst medical professionals has led to widespread use for both networking and education. Limited professional guidance exists on the sharing of medical imagery on these platforms. This Comment explores consent and offers reflective advice on the use of medical images on social media…