Patient experience of informed consent for diagnostic coronary angiogram and follow-on treatments
Research and Development
Howard T Blanchard, Diane L Carroll, Felicity Astin
British Journal of Cardiac Nursing, 1 June 2022; 17(5)
Abstract
Background/Aims
Coronary angiography requires a complex informed consent process as a legal and ethical requirement before treatment. This process may allow percutaneous coronary intervention to be completed as a continuation of a coronary angiography. Patients routinely consent to both interventions, but over one-quarter will only receive the diagnostic angiogram. This study explored views and understandings of the informed consent process, and associations with demographic characteristics, among patients who consented to coronary angiography and same-setting percutaneous coronary intervention, but were found to be ineligible for the latter.
Methods
A descriptive cross-sectional survey design was used to explore patients’ views. A total of 62 participants (73% male, mean age 68.4 years) completed a 36-item survey the day after undergoing diagnostic coronary angiography.
Results
Female participants reported greater difficulty in recalling treatment information (P<0.03), found discussions about alternative treatments more confusing (P<0.02), and the disclosure of comprehensive risk information more of a deterrent to consent for treatment (P<0.02) compared to men. Higher levels of education were associated with greater preference for information and involvement in treatment decisions (P<0.002).
Conclusions
Patients who give informed consent for diagnostic coronary angiography with or without a same-setting percutaneous coronary intervention need clear comprehensive information regarding alternative options. By recognising the patient’s need for information, nurses can provide an individualised explanation and reinforcement of the information provided during informed consent.

Standardization of informed consent for oral chemotherapeutic agents
Meeting Abstract
Angela Pennisi, Kathleen Kiernan Harnden, Lauren Ann Mauro, Patricia Conrad Rizzo, Ghana Kang, Maya Leiva, Seung Yom
Journal of Clinical Oncology, 1 June 2022 [2022 ASCO Annual Meeting]
Abstract
Background
Informed consent is an essential prerequisite to the administration of any oral or parenteral chemotherapeutic agent. Obtaining informed consent for treatment is the oncologist’s responsibility and all the information the oncologist and patient share and agree to in this process should be documented in the patient’s medical record. Informed consents at Inova Schar Cancer Institute are created through an electronic consent, a web-based solution that creates procedure-specific consent forms that can be used for treatments and procedures for patients and is integrated in our electronic medical record system. While the oncology nurse administering parenteral chemotherapy ensures that the consent is signed before infusion starts, no clear plan existed at our institution for patients starting oral chemotherapeutic agents. In addition, with the transition to telemedicine visits during covid-19 pandemic, patients are often not in clinic at time of discussion of the new treatment plan with the oncologist or for chemotherapy teaching session therefore creating a barrier to obtain consent on the computer pad. The aim of this study is to standardize methods to obtain written informed consent for oral chemotherapy agents with 100% compliance.
Methods
Our first Plan-Do-Study-Act (PDSA) cycle conducted in the breast medical oncology clinic included the following steps: 1) the oncologist or the registered pharmacist (RPH) creates the electronic consent 2) after completion of chemotherapy teaching session, the RPH ensures that the patient and the physician have signed the consent and also signs as witness. In this first cycle we also tested the “mobile sign” modality that allows to text the informed consent to the patients so they can sign directly on their mobile phone if the teaching is conducted remotely.
Results
Baseline chart audit of seven patients who were started on oral chemotherapy regimen during the month of December 2021 revealed that all the patients received chemotherapy teaching, but none provided written informed consent. After implementation of above steps for two weeks, chart audit of five patients showed that all signed informed consent that was also completed by physician’s and witness’s signature. Two patients were successfully consented through the “mobile sign” modality.
Conclusions
Our study identified failure to obtain written informed consent for oral chemotherapeutic agents with some barriers created by increasing use of telemedicine. As all our patients receive chemotherapy teaching sessions, we identified this as best timing to obtain informed consent as patients have received comprehensive education on the chemotherapy agent. We also explore the option of “mobile sign” if the teaching session is conducted virtually. Our preliminary results showed 100% compliance in obtaining informed consent and feasible use of “mobile sign” option. We plan for long term chart audits to confirm above results.

Surgical Documentation, Informed Consent, and Operative Note
Book Chapter
Andreas M. Kaiser
Chassin’s Operative Strategy in General Surgery, 29 May 2022; pp 89–91 [Springer]
Abstract
This chapter defines the value and describes the elements of good surgical documentation, and gives the fundamentals of writing a good operative note. Solid documentation is our friend as well as our “protective insurance,” while poor, incomplete, or altered documentation can easily turn into our worst enemy. But the value of documentation is not just defined by its role in litigation cases but by its importance for continuity of care, cost-saving measures, reimbursement, as well as quality control and research efforts.

Adherence to a national consensus statement on informed consent: medical students’ experience of obtaining informed consent from patients for sensitive examinations
Harsh Bhoopatkar, Carlos F C Campos, Phillipa J Malpas, Andy M. Wearn
The New Zealand Medical Journal, May 20, 2022; 135 pp 10-18
Open Access
Abstract
Aim
To determine whether the guidance from the New Zealand medical programmes’ national consensus statement on obtaining informed consent from patients for sensitive examinations are being met, and to explore medical students’ experience of obtaining consent.
Method
A self-reported, online, anonymous questionnaire was developed. Data were collected in the period just after graduation from final year medical students at The University of Auckland in 2019.
Results
The response rate was 35% (93/265). Most students reported that they were “not always compliant” with the national consensus statement for obtaining informed consent for almost all sensitive examinations. The main exception was for the female pelvic examination (not in labour) under anaesthesia, where most students reported being “always compliant”. We identified factors related to students, supervisors, institution, and the learning context as reasons for lack of compliance.
Conclusion
Adherence to the national consensus statement on obtaining informed consent for sensitive examinations is unsatisfactory. The medical programme needs to review the reasons for lapses in implementing the policy in practice, to ensure a safe learning environment for patients and our students.

Importance of Informed Consent in Clinical Practice
Original Investigation
Işıl Pakiş, Gülfer Bektaş, Berat Akif Kaya, Cenk Hilmi Kılıç
Istanbul Medical Journal, 2022; 23(2) pp 139-43
Open Access
Abstract
Introduction
This study aims to determine the experiences and opinions of physicians on informed consent practices, to research their awareness of their legal responsibilities, and to provide solutions to the problems encountered in practice.
Methods
This research is a descriptive field study. One hundred and eighty-four physicians working in a state hospital in İstanbul participated in this study between January 15 and February 15, 2018. The questionnaire form was used as a data collection tool. After the participants were informed about the purpose and method of the research, their consent was obtained, and they were asked to fill in the questionnaire forms. The analysis of the data was performed using the SPSS 18.00 program. The significance level was accepted as p<0.05.
Results
One hundred and eighty-four physicians working in a state hospital in İstanbul participated in this study. 69% (n=127) of the physicians participating in the study were male and 31% (n=57) were female. 35.3% (n=65) of the participants were from the 30-39 years old age group. 96.7% (n=178) of the physicians in the study stated that they personally informed their patients before the surgical interventions. 83.7% (n=154) of the physicians think that the lawsuits filed against the physicians due to medical malpractice affect the health services provided by the physicians to their patients.61.4% of the participants (n=113) think that they have not received enough education in their medical education processes regarding the rights and obligations of the physicians.
Conclusion
Considering the current situation in Turkey, the informed consent process is not yet at the level it should be. Since human rights are in the process of development in the world, informed consent and many more patient rights will gain importance with studies on this subject. Therefore, training, and studies should be increased to inform physicians and patients about informed consent and to make them a behavioral model physicians.

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.