Informed consent, shared-decision making and a reasonable patient’s wishes based on a cross-sectional, national survey in the USA using a hypothetical scenario

Informed consent, shared-decision making and a reasonable patient’s wishes based on a cross-sectional, national survey in the USA using a hypothetical scenario
Research 
John T James, Darwin Jay Eakins, Robert R Scully
BMJ, 30 July 2019; 9(7)
Open Access
Abstract
Objective 
In approximately half the states in the USA, and more recently in the UK, informed consent is legally defined as what a reasonable patient would wish to know. Our objective was to discern the information needs of a hospitalised, ‘reasonable patient’ during the informed-consent process.
Design 
We performed a cross-sectional study to develop a survey instrument and better define ‘reasonable person’ in relation to informed consent in a hypothetical scenario where an invasive procedure may be an option.
Setting 
A 10-question survey was administered from April 19 through 22 October 2018 to three groups: student nurses (n=76), health professions educators (n=63) and a US national population (n=1067).
Primary and secondary outcome measures 
The primary outcome measure was the average intensity, on a 5-point scale, by which survey groups wished to have each of 10 questions answered. The secondary outcome was to discern relationships between survey demographics and the intensity by which participants wanted an answer.
Results 
Despite substantial demographic differences in the nursing-student group and health-professions-educator group, the average intensity scores were within 0.2 units on nine of 10 questions. The national survey revealed a strong desire to have an answer to each question (range 3.98–4.60 units). It showed that women desired answers more than men and older adults desired answers more than younger adults.
Conclusions 
Based on responses to 10 survey questions regarding wishes of people in a situation where an invasive procedure may be necessary, the vast majority want an answer to each question. They wanted to know about all treatment options, risky drugs, decision aids, who will perform the procedure, and the cost. They wanted their advocate present, periodic review of their medical record, a full day to review documents and expected outcomes and restrictions after the procedure.

Say what? Patients have poor immediate memory of major risks of interscalene block disclosed during the informed consent discussion

Say what? Patients have poor immediate memory of major risks of interscalene block disclosed during the informed consent discussion
Original Article
Johnny Wei Bai, Faraj W W Abdallah, Melanie Cohn, Stephanie Ladowski, Poorna Madhusudan, Richard Brull
Regional Anesthesia & Pain Medicine, 23 August 2019
Abstract
Background 
Poor memory of disclosed risks can undermine informed consent and create medicolegal challenges. The extent to which patients remember the risks of peripheral nerve blockade following the informed consent discussion is unknown. This prospective cohort study evaluated patients’ immediate memory of risks related to interscalene block (ISB) that were disclosed during the preoperative informed consent discussion.
Methods 
Using a standardized script, patients scheduled for arthroscopic shoulder surgery were informed of the risks of ISB by an anesthesiologist in the preoperative assessment clinic. Immediately thereafter, consenting participants were asked to identify the risks of ISB from a printed list of nine true risks (four major and five minor) and nine ‘distractor’ items, which were unrelated adverse events and not disclosed. The primary outcome was the proportion of participants who remembered all four true major risks including long-term nerve damage, seizure, life-threatening event, and damage to the covering of the lung.
Results 
Among 125 participants, only 26 (21%) remembered all four major risks of ISB. The mean number of major risks remembered was 2±1 out of 4. Fifteen (12%) participants remembered all nine true risks. The mean number of true risks remembered was 6±2 out of 9. Multivariable analysis revealed that participants’ self-rated assessment of their memory was not associated with actual recall.
Conclusion 
Patients have poor immediate memory of the major risks related to ISB disclosed during the informed consent discussion. Under the present study conditions, the validity of the informed consent process for patients undergoing ISB may be undermined.

Obtaining consent for obstetric procedures

Obtaining consent for obstetric procedures
KatrinaHenderson, SiânGriffiths
Anaesthesia & Intensive Care Medicine, 19 August 2019
Abstract
Consent is a process that involves information disclosure of a proposed treatment or intervention. It includes a discussion of the risks relevant to that particular patient as well as the benefits and alternative options. The process must be clearly documented to provide a legal justification for treatment. Obtaining informed consent can be a challenge when a labouring woman is in severe pain or under the influence of strong analgesics. High-risk women should be encouraged to attend pre-assessment clinics to enable adequate time to process the information discussed. Pregnant women are presumed competent and are entitled to refuse treatment even if this risks their life or the life of their fetus. Rarely, if a woman is not considered competent to make decisions for herself, clinicians should take into account the underlying reasons and consider proceeding in their best interests under the doctrine of necessity or apply to the courts for approval of an intervention. This article summarizes current guidelines in relation to consent that have been updated to reflect recent case law.

Deferred consent for delivery room studies: the providers’ perspective

Deferred consent for delivery room studies: the providers’ perspective
Original Article
Maria C den Boer, Mirjam Houtlosser, Elizabeth E Foglia, Enrico Lopriore, Martine Charlotte de Vries, Dirk P Engberts, Arjan B te Pas
Archives of Disease in Childhood: Fetal & Neonatal, 19 August 2019
Abstract
Objective 
To gain insight into neonatal care providers’ perceptions of deferred consent for delivery room (DR) studies in actual scenarios.
Methods 
We conducted semistructured interviews with 46 neonatal intensive care unit (NICU) staff members of the Leiden University Medical Center (the Netherlands) and the Hospital of the University of Pennsylvania (USA). At the time interviews were conducted, both NICUs conducted the same DR studies, but differed in their consent approaches. Interviews were audio-recorded, transcribed and analysed using the qualitative data analysis software Atlas.ti V.7.0.
Results                                                       
Although providers reported to regard the prospective consent approach as the most preferable consent approach, they acknowledged that a deferred consent approach is needed for high-quality DR management. However, providers reported concerns about parental autonomy, approaching parents for consent and ethical review of study protocols that include a deferred consent approach. Providers furthermore differed in perceived appropriateness of a deferred consent approach for the studies that were being conducted at their NICUs. Providers with first-hand experience with deferred consent reported positive experiences that they attributed to appropriate communication and timing of approaching parents for consent.
Conclusion 
Insight into providers’ perceptions of deferred consent for DR studies in actual scenarios suggests that a deferred consent approach is considered acceptable, but that actual usage of the approach for DR studies can be improved on.

Attitudes, Beliefs, and Practices of Aesthetic Plastic Surgeons Regarding Informed Consent

Attitudes, Beliefs, and Practices of Aesthetic Plastic Surgeons Regarding Informed Consent
Accepted Manuscript
Chelsea O Hagopian, Teresa B Ades, Thomas M Hagopian, Erik M Wolfswinkel, W Grant Stevens
Aesthetic Surgery Journal, 30 July 2019
Abstract
Background
Best practice for informed consent in aesthetic plastic surgery is a process of shared decision-making (SDM), yet evidence strongly suggests this is not commonly reflected in practice nor is it supported by traditional informed consent documents (ICD). Falsely held beliefs by clinicians about SDM may contribute to its lack of adoption.
Objective
To understand the baseline attitudes, beliefs, and practices of informed consent among board-certified plastic surgeons with a primarily aesthetics practice.
Methods
A 15-question online survey was emailed to active members of the American Society for Aesthetic Plastic Society (ASAPS). Items included: demographics, Likert scales, free-text, acceptability, and one question seeking consensus on general information all patients must understand before any surgery.
Results
This survey appreciated a 13% response rate with a 52% completion rate across 10 countries and 31 U.S. states. 69% are very-extremely confident that ICD contain evidence-based information. 63% are not at all-not so confident in ICD effectiveness of prompting patients to teach-back essential information. 51% believe surgical ICD should be reviewed annually. 86% report assistance with patient education during informed consent. “ASAPS members” should be a source of evidence for content (free-text). 63% were somewhat-very satisfied with the survey and 84% will probably-definitely yes participate in future surveys.
Conclusions
Findings echo concerns in the literature that ICD are focused on disclosure not patient understanding. There is notable concern regarding information overload and retention, but less regarding the quality and completeness of information. Current culture suggests key clinician stakeholders are amenable to change.

Informed Consent: A Monthly Review
___________________________

August 2019

This digest aggregates and distills key content around 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 GE2P2 Global Foundation’s Center for Informed Consent Integrity, which is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Fellow
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org

Publisher
David R. Curry
President & CEO
GE2P2 Global Foundation
david.r.curry@ge2p2global.org

PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_August 2019

Consent for clinical genome sequencing: considerations from the Clinical Sequencing Exploratory Research Consortium

Consent for clinical genome sequencing: considerations from the Clinical Sequencing Exploratory Research Consortium
Yu JH, Appelbaum PS, Brothers KB, Joffe S, Kauffman TL, Koenig BA, Prince AE, Scollon S, Wolf SM, Bernhardt BA, Wilfond BS
Personalized Medicine, 17 Jul 2019
Abstract
Implementing genome and exome sequencing in clinical practice presents challenges, including obtaining meaningful informed consent. Consent may be challenging due to test limitations such as uncertainties associated with test results and interpretation, complexity created by the potential for additional findings and high patient expectations. We drew on the experiences of research teams within the Clinical Sequencing Exploratory Research (CSER1) Consortium on informed consent for clinical genome and exome sequencing (CGES) to negotiate consensus considerations. We present six considerations for clinicians and 12 key points to communicate as they support patients in deciding whether to undergo CGES. These considerations and key points provide a helpful starting point for informed consent to CGES, grounded in the Clinical Sequencing Exploratory Research (CSER1) experience.

Informed consent and community engagement in open field research: lessons for gene drive science

Informed consent and community engagement in open field research: lessons for gene drive science
Debate                                      
Jerome Amir Singh
BMC Medical Ethics, 27 July 2019; 20(54) 
Open Access
Abstract
Background
The development of the CRISPR/Cas9 gene editing system has generated new possibilities for the use of gene drive constructs to reduce or suppress mosquito populations to levels that do not support disease transmission. Despite this prospect, social resistance to genetically modified organisms remains high. Gene drive open field research thus raises important questions regarding what is owed to those who may not consent to such research, or those could be affected by the proposed research, but whose consent is not solicited. The precise circumstances under which informed consent must be obtained, and from whom, requires careful consideration. Furthermore, appropriate engagement processes should be central to any introduction of genetically modified mosquitos in proposed target settings.
Discussion
In this work, international guidance documents on informed consent and engagement are reviewed and applied to the genetically modified mosquito research context. Five analogous research endeavours that involve area-wide / open field experiments are reviewed. The approach of each in respect to the solicitation of individual informed consent and community engagement are highlighted.
Conclusions
While the solicitation of individual informed consent in host settings of gene drive field trials may not be possible or feasible in some instances, local community and stakeholder engagement will be key to building trust towards the proposed conduct of such research. In this regard, the approaches taken by investigators and sponsors of political science field research and weather modification field research should be avoided. Rather, proponents of gene drive field research should look to the Eliminate Dengue field trials, cluster randomised trials, and pragmatic clinical trials for guidance regarding how the solicitation of individual informed consent of host communities ought to be managed, and how these communities ought to be engaged.

Optimising informed consent in school-based adolescent vaccination programmes in England: A multiple methods analysis

Optimising informed consent in school-based adolescent vaccination programmes in England: A multiple methods analysis
Tracey Chantler, Louise Letley, Pauline Paterson, Joanne Yarwood, Vanessa Saliba, Sandra Mounier-Jack
Vaccine, 24 July 2019
Open Access
Abstract
The process of obtaining informed consent for school-based adolescent immunisation provides an opportunity to engage families. However, the fact that parental consent needs to be obtained remotely adds complexity to the process and can have a detrimental effect on vaccine uptake. We conducted a multiple methods analysis to examine the practice of obtaining informed consent in adolescent immunisation programmes. This involved a thematic analysis of consent related data from 39 interviews with immunisation managers and providers collected as part of a 2017 service evaluation of the English adolescent girls’ HPV vaccine programme and a descriptive statistical analysis of data from questions related to consent included in a 2017 survey of parents’ and adolescents’ attitudes to adolescent vaccination. The findings indicated that the non-return of consent forms was a significant logistical challenge for immunisation teams, and some were piloting opt-out consent mechanisms, increasing the proportion of adolescents consenting for their own immunisations, and introducing electronic consent. Communicating vaccine related information to parents and schools and managing uncertainties about obtaining adolescent self-consent for vaccination were the main practical challenges encountered. Survey data showed that parents and adolescents generally agreed on vaccine decisions although only 32% of parents discussed vaccination with their teenager. Parental awareness about the option for adolescents to self-consent for vaccination was limited and adolescents favoured leaving the decision-making to parents. From the interviews and variability of consent forms it was evident that health professionals were not always clear about the best way to manage the consent process. Some were also unfamiliar with self-consent processes and lacked confidence in assessing for ‘Gillick competency’. Developing pathways and related interventions to improve the logistics and practice of consent in school-based adolescent immunisation programmes could help improve uptake.

Vaccination over Parental Objection — Should Adolescents Be Allowed to Consent to Receiving Vaccines?

Vaccination over Parental Objection — Should Adolescents Be Allowed to Consent to Receiving Vaccines?
Perspective
Ross D. Silverman, Douglas J. Opel, Saad B. Omer
New England Journal of Medicine, 11 July 2019; 381(2)
Excerpt
…Such cases raise the question of whether adolescent minors should be able to consent to vaccinations without parental permission. For minors to be able to choose to be vaccinated over parental objections, most states would need to make substantive changes to laws governing medical consent. Since children are generally considered nonautonomous under U.S. law, treatment of a child in a medical setting requires parental permission, typically until a child reaches 18 years of age. Parents are generally given broad discretion in making decisions on behalf of their children, in part because they know their child best, are positioned to weigh competing family interests, and are permitted to raise their child as they choose. Such discretion doesn’t mean that adolescents have no role in decisions that affect them, however. Out of respect for adolescents’ developing autonomy, clinicians routinely explore their understanding of health-related issues, solicit their agreement on care plans, navigate discordance between parental and adolescent preferences, and protect adolescents’ confidentiality interests.

Both ethical principles and state laws also support independent decision making by adolescents in cases in which failing to grant adolescents autonomy could foreseeably result in substantial risk to the minor or to public health. For instance, all states have laws permitting minors to make independent, confidential clinical decisions regarding certain sensitive or stigmatized health care services, such as those related to sexual health, reproduction, mental health, and substance use disorders. Roughly 20% of jurisdictions require adolescents to be at least 12 or 14 years of age to make such decisions; others don’t designate a minimum age of consent.3 A court may also grant an older adolescent (typically 16 years or older) legal emancipation or deem the adolescent to be a “mature minor” who is able to make certain decisions independently.

Most states, however, don’t authorize adolescents to independently consent to vaccination…