Evolution of Investigating Informed Assent Discussions about CPR in Seriously Ill Patients
Renee D. Stapleton, Dee W. Ford, Katherine R. Sterba, Nandita R. Nadig, Steven Ades, Anthony L. Back, Shannon S. Carson, Katharine L. Cheung, Janet Ely, Erin K. Kross, Robert C. Macauley, Jennifer M. Maguire, Theodore W. Marcy, Jennifer J. McEntee, Prema R. Menon, Amanda Overstreet, Christine S. Ritchie, Blair Wendlandt, Sara S. Ardren, Michael Balassone, Stephanie Burns, Summer Choudhury, Sandra Diehl, Ellen McCown, Elizabeth L. Nielsen, Sudiptho R. Paul, Colleen Rice, Katherine K. Taylor, Ruth A. Engelberg
Journal of Pain and Symptom Management, June 2022; 63(6) e621-e632
Abstract
Context
Outcomes after cardiopulmonary resuscitation (CPR) remain poor. We have spent 10 years investigating an “informed assent” (IA) approach to discussing CPR with chronically ill patients/families. IA is a discussion framework whereby patients extremely unlikely to benefit from CPR are informed that unless they disagree, CPR will not be performed because it will not help achieve their goals, thus removing the burden of decision-making from the patient/family, while they retain an opportunity to disagree.
Objectives
Determine the acceptability and efficacy of IA discussions about CPR with older chronically ill patients/families.
Methods
This multi-site research occurred in three stages. Stage I determined acceptability of the intervention through focus groups of patients with advanced COPD or malignancy, family members, and physicians. Stage II was an ambulatory pilot randomized controlled trial (RCT) of the IA discussion. Stage III is an ongoing phase 2 RCT of IA versus attention control in in patients with advanced chronic illness.
Results
Our qualitative work found the IA approach was acceptable to most patients, families, and physicians. The pilot RCT demonstrated feasibility and showed an increase in participants in the intervention group changing from “full code” to “do not resuscitate” within two weeks after the intervention. However, Stages I and II found that IA is best suited to inpatients. Our phase 2 RCT in older hospitalized seriously ill patients is ongoing; results are pending.
Conclusions
IA is a feasible and reasonable approach to CPR discussions in selected patient populations.

Consent in Interventional Radiology—How Can We Make It Better?
Review Article
Tia Forsman, Sara Silberstein, Eric J. Keller
Canadian Association of Radiologists Journal, 25 May 2022
Abstract
Informed consent is an important part of the clinician-patient relationship. However, studies suggest consent practices tend to be limited in consistency and completeness. This may be particularly challenging for interventional radiology given more limited public awareness and the often fast-paced, dynamic nature of our practices. This article reviews these challenges as well as ideal consent practices and potential approaches to improve consent in interventional radiology.

Development of Shared Decision-Making Training Module for Patients Facing Preference-Sensitive Decisions regarding Major Surgical Procedures
Poster Abstracts
Ryan Gainer, Greg Hirsch, Elias Hirsch
International Journal of Integrated Care, 16 May 2022
Abstract
Introduction
Studies of surgical decision making demonstrate poor decisional quality, especially patient comprehension and expression of preferences. Shared decision making (SDM), a formalized approach wherein patients are educated about risks, benefits to treatment options, and supported to share personal preferences, has been shown to improve comprehension, reduce decisional conflict, and better align patient expectations with outcome, however multiple systematic reviews have demonstrated almost no sustained uptake of this approach in surgery. The goal of this study is to implement SDM with relevant training aimed at the surgical team with a pre-post design that measures effectiveness through Option-5 scoring of informed-consent interactions.
Aims Objectives Theory or Methods
Five focus groups with patients (n=2) and health care providers (HCPs) (n=3) were carried out to determine barriers and facilitators of SDM and learning preferences for HCPs. Common barriers and facilitators identified in focus groups using thematic analysis were used to develop communication and logistical strategies included in the training. HCP learning preferences identified informed format and presentation style of the training to improve participant engagement. Informed consent discussions were audio recorded and analyzed using Option-5 methodology which comprises a 5 item measure of SDM used to assess the extent to which clinicians involve patients in the decision making process.
Highlights or Results or Key Findings
Common barriers to SDM identified in thematic analysis included; lack of time during surgeon patient interaction; authoritative imbalance between patients and clinicians; and deficits in patient comprehension. HCPs expressed preferences regarding presentation style and format specifically; synchronous short events with relevant examples. Pre-intervention OPTION-5 scoring (n=40) demonstrated low decisional quality (average score 27/100) with almost no perceptible elicitation or incorporation of patient preferences during consent discussions. Following the training of cardiac surgeons and multidisciplinary team members, 62 more informed consent discussions will be audio-recorded and evaluated using the OPTION-5 scoring metric. OPTION-5 scores before and after training will be compared by item and total score to determine change in informed consent discussion quality.
Conclusions
Informed consent in surgery is lacking in SDM approaches. Barriers have been identified and SDM training has been developed with a team based approach in mind. Effectiveness of the training intervention on the improvement of surgical consent discussion quality will be measured using OPTION-5 and if successful broader implementation will
Implications for applicability/transferability sustainability and limitations
Successful implementation of SDM training showing measurable improvement in cardiac surgery informed consent discussion quality will substantiate the implementation of SDM training modules specified for other surgical disciplines as well as subsequent evaluation of long term sustainability of the effects of SDM training.

Barriers to Informed Consent in Interventional Radiology: A Pilot Study
Sara Silberstein, Eric J.Keller
Journal of Radiology Nursing, 9 May 2022
Abstract
Background
Informed consent is a central part of the relationships between patients and interventional radiology teams, but consent practices are variable and limited.
Purpose
This study explored consent practices among clinicians and staff in an academic IR department to identify barriers to informed consent.
Methods
Systematic interviews were conducted with 17 clinicians and staff about their roles in obtaining informed consent, perceptions of what informed consent and capacity determinations entail, and barriers to patients’ understanding of IR procedures.
Findings
Results revealed four key barriers to adequate informed consent: limited procedural experience/knowledge by the consenting clinician, unclear division of responsibilities, inconsistent approaches to assessing capacity and surrogate decision making, and wide variation in patients’ baseline understandings.
Discussion
This variation seemed to stem from a lack of shared understanding about consent processes and responsibilities, highlighting an important area for quality improvement in IR that would benefit from a larger multipractice investigation of consent practices.

Poor compliance documenting informed consent in trauma patients with distal radius fractures compared to elective total knee arthroplasty
Scott M Bolam, Leigh Munro, Mark Wright
Royal Australasian College of Surgeons, 4 May 2022
Open Access
Abstract
Background
The purpose of this study was (1) to evaluate the adequacy of informed consent documentation in the trauma setting for distal radius fracture surgery compared with the elective setting for total knee arthroplasty (TKA) at a large public hospital and (2) to explore the relevant guidelines in New Zealand relating to consent documentation.
Methods
Consecutive adult patients (≥16 years) undergoing operations for distal radius fractures and elective TKA over a 12-month period in a single-centre were retrospectively identified. All medical records were reviewed for the risks and complications recorded. The consent form was analysed using the Flesch Reading Ease Score (FRES) and the Simple Measure of Gobbledygook (SMOG) index readability scores.
Results
A total of 133 patients undergoing 134 operations for 135 distal radius fractures and 239 patients undergoing 247 TKA were included. Specific risks of surgery were recorded significantly less frequently for distal radius fractures than TKA (43.3% versus 78.5%, P < 0.001). Significantly fewer risks were recorded in the trauma setting compared to the elective (2.35 ± 2.98 versus 4.95 ± 3.33, P < 0.001). The readability of the consent form was 40.5 using the FRES and 10.9 using the SMOG index, indicating a university undergraduate level of reading.
Conclusions
This study has shown poor compliance in documenting risks of surgery during the informed consent process in an acute trauma setting compared to elective arthroplasty. Institutions must prioritize improving documentation of informed consent for orthopaedic trauma patients to ensure a patient-centred approach to healthcare.

A Systematic Review on Improving the Family Experience After Consent for Deceased Organ Donation
Review Article
Sonja Bjelland, Krista Jones
Progress in Transplantation, 2 May 2022
Abstract
Introduction
The demand for transplanted organs outweighs the supply and intensifies the need to improve care for donor families. Studies have shown inadequate care by hospital staff can increase posttraumatic stress disorder and complicated grief in these families but putting solutions into practice remains slow.
Objective
This systematic review identified factors that relieve or contribute to distress for deceased organ donor families in the time since the decision to donate. Additionally, it provides insights into potential improvements at public health, educational, and health system levels to address these deficiencies.
Methods
Search terms included organ don*, famil* or relati*, family-centered, grief, and experience*. The search covered original research articles, published in English, from 2014 to July 2021.
Results
Four key themes emerged among the studies. (a) Understanding factors that affect the emotional aftermath can help staff prevent posttraumatic stress disorder and complicated grief. (b) Improving communication by hospital staff includes: avoiding medical jargon, providing adequate audio and visual explanations, and understanding that the next of kin is struggling to comprehend the tragedy and the information they are being told. (c) End-of-life care such as memory making, bringing in palliative care resources, and parting ceremonies can assist with familial coping as well as staff interactions. (d) Families want more support in the months and years after the donation decision.
Discussion
Changes at multiple levels can improve the quality of care for families whose relative gave the gift of life, but more research and translation into practice are needed.

Consent: risk assessment, risk communication and shared decision making
Jayne M. Sewell, Catherine Rimmer
Surgery (Oxford), 30 April 2022
Abstract
The consent process is the foundation of the modern doctor–patient relationship, and can present a challenge to doctors. The consent process can be complex, and often involves the interaction of many different factors, including ethical and legal considerations. A shared decision-making process allows for full consideration of the treatment options available, and takes into account individual patient’s concerns and preferences. Ensuring that the patient is fully informed requires a thorough understanding of the risks of an intervention for that particular patient; therefore, individualized risk assessment is of fundamental importance. Using a combination of individual patient information, formalized investigations, and population data, gives the most complete assessment of risk. Communicating that risk information to patients is key, and the doctor should always use clear language and avoid bias. The use of visual aids and information leaflets, and the avoidance of vague language and complex statistical terms, will help the patient to develop a more complete understanding of the risks they face.

An Ethical Defense of a Mandated Choice Consent Procedure for Deceased Organ Donation
Original Paper
Xavier Symons, Billy Poulden
Asian Bioethics Review, 29 April 2022
Open Access
Abstract
Organ transplant shortages are ubiquitous in healthcare systems around the world. In response, several commentators have argued for the adoption of an opt-out policy for organ transplantation, whereby individuals would by default be registered as organ donors unless they informed authorities of their desire to opt-out. This may potentially lead to an increase in donation rates. An opt-out system, however, presumes consent even when it is evident that a significant minority are resistant to organ donation. In this article, we defend a mandated choice framework for consent to deceased organ donation. A mandated choice framework, coupled with good public education, would likely increase donation rates. More importantly, however, a mandated choice framework would respect the autonomous preferences of people who do not wish to donate. We focus in particular on the Australian healthcare context, and consider how a mandated choice system could function as an ethical means to increase the organ donation rate in Australia. We make the novel proposal that all individuals who vote at an Australian federal election be required to state their organ donation preferences when voting.

Patient Experience of Informed Consent for Diagnostic Coronary Angiogram and Follow-On Treatments: A Research Brief
Diane L. Carroll, Howard T Blanchard, Felicity Astin
Journal British Journal of Cardiac Nursing, 25 April 2022
Abstract
Background/Aims
Coronary angiography requires a complex informed consent process, a legal and ethical requirement before treatment, which may allow percutaneous coronary intervention (PCI) to be completed as a continuation of a coronary angiography. Patients are routinely consented for both interventions, but over a quarter will only receive diagnostic angiogram. Therefore, the specific aim of this study is to describe patients’ demography, views and understanding of the informed consent process, in patients who gave informed consent for coronary angiography and same setting PCI but were found to be ineligible for same setting PCI.
Methods
A descriptive cross sectional survey design was used to explore these patients’ views. Participants completed a 36-item survey on the day after diagnostic coronary angiography.
Results
Data was collected from a convenience sample of 62 subjects, 73% male, 68% college educated, 40% working with a mean age of 68.4 (11.4) years. Women reported; greater difficulty in recalling treatment information (p<.03) found discussions about alternative treatments more confusing (p<.02), and the disclosure of comprehensive risk information a deterrent to consent 2 for treatment (p<.02), when compared to men. Higher levels of education were associated with greater preference for information and involvement in treatment decisions (p<.002).
Conclusions
Patients who participate in an informed consent for diagnostic coronary angiography with, or without, a same-setting PCI need clear comprehensive information on alternatives. Recognizing patient’s need for information is an opportunity for nursing to provide individualized explanation and reinforcement of the information provided during informed consent