Informed Consent before coronary angiography and percutaneous coronary intervention from the patient’s perspective: A picture is worth a thousand words

Informed Consent before coronary angiography and percutaneous coronary intervention from the patient’s perspective: A picture is worth a thousand words
Brand, C. Crayen, A. Hamann, S. Martineck, L. Gao, H. Brand, S.M. Squier, K. Stangl, F. Kendel, V. Stangl
IJC Heart & Vasculature, August 2022; 41
Abstract
Background
Patients scheduled for coronary angiography may feel insufficiently informed about the planned procedure. We aimed to evaluate the patient-rated quality of the Informed Consent (IC) process and to investigate the efficacy of medical graphics to assist and improve the IC procedure.
Methods
A graphic-based information broschure illustrating central steps of the procedure was created in collaboration with scientific illustrators. In a randomized, controlled, prospective trial, 121 patients undergoing coronary angiography/PCI were randomized to a group obtaining the usual IC (Control group) or to a group that additionally obtained a graphic-based IC (Comic group). The perceived quality of the IC was compared between groups using single items of the Client Satisfaction Questionnaire-8 and self-designed single items.
Results
Only 67.8% of patients stated to have completely read the standard written IC sheet. The quality of the IC was perceived to be very good in 45.0% of patients in the Comic group compared to 24.6% in the Control group (p =.023). 57.4% of the Control group compared to 76.7% of the Comic group stated that all of their questions were satisfactorily adressed (p =.015). 43.3% of the Comic group, in contrast to only 18.0% of the Control group, declared to feel „very satisfied“ with the obtained IC procedure (p =.002). The acceptance of this new IC approach was very high: no patient expressed feelings of not being taken seriously when reading medical graphics.
Conclusions
Our data confirm pronounced limitations of the usual IC practice. The use of medical graphics positively impacts on patient-evaluated endpoints and may significantly improve the IC procedure.

Informed consent for suspension microlaryngoscopy: what should we tell the patient? A consensus statement of the European Laryngological Society

Informed consent for suspension microlaryngoscopy: what should we tell the patient? A consensus statement of the European Laryngological Society
Frederik G. Dikkers, Michel R. M. San Giorgi, Rico N. P. M. Rinkel, Marc Remacle, Antoine Giovanni, Małgorzata Wierzbicka, Riaz Seedat, Guillermo Campos, Guri S. Sandhu
European Archives of Oto-Rhino-Laryngology, 12 July 2022
Open Access
Abstract
Introduction
Informed consent for any surgical intervention is necessary, as only well-informed patients can actively participate in the decision-making process about their care, and better understand the likely or potential outcomes of their treatment. No consensus exists on informed consent for suspension microlaryngoscopy (SML).
Materials and methods
Informed consent procedures in nine countries on five continents were studied.
Results
Several risks can be discerned: risks of SML as procedure, anesthesiologic risks of SML, specific risks of phonosurgery, risks of inadequate glottic exposure or unexpected findings, risks of not treating. SML has recognized potential complications, that can be divided in temporary (minor) complications, and lasting (major) complications.
Conclusion
SML is a safe procedure with low morbidity, and virtually no mortality. Eleven recommendations are provided.

Patients’ satisfaction and associated factors towards preoperative informed consent process: A cross-sectional study

Patients’ satisfaction and associated factors towards preoperative informed consent process: A cross-sectional study
Tamiru Tilahun Ayele, Tadese Tamire Negash, Keder Essa oumer, Aderajew Mekuanint, Diriba Teshome, Efrem Fenta, Yewlsew Fentie, Aragaw Tesfaw Ashenafi Tolosa
Annals of Medicine and Surgery, 4 July 2022; 79
Abstract
Background
Informed consent is a process that needs time and effort to satisfy patients’ desires. Patient dissatisfaction on preoperative informed consent process may be caused by multiple factors of clinical practice. This study aimed to assess patients’ satisfaction and associated factors of informed consent process among elective surgical patients.
Methods
A cross-sectional study was conducted on 404 postoperative patients who signed the informed consent for elective surgery. A systematic sampling technique was applied to select the study participants. Modified Leiden perioperative patient satisfaction tool was adapted to assess patients’ satisfaction with preoperative informed consent process. Data were entered in to Epi-data version 4.20 and exported to SPSS version 20 for analysis. Bivariate and multivariable logistic regression was computed to identify independent variables associated with patient satisfaction towards preoperative informed consent process. A p-value of less than 0.05 was used to declare the statistical significance.
Results
The overall satisfaction of patients with preoperative informed consent process was 70.3%. Multivariable logistic regression analysis revealed that, being male (AOR: 4.75, 95% CI: 2.47–9.16), primary school (AOR: 8.42, 95% CI: 4.74–7.55), secondary school (AOR: 2.17, 95% CI: 5.74–8.62), rural residence (AOR: 1.8, 95% CI: 2.1–3.9) and received general anesthesia (AOR: 2.92, 95% CI: 1.62–5.26) were significantly associated with patients’ satisfaction with the informed consent process.
Conclusion
The overall patients’ satisfaction on preoperative informed consent process was relatively low. Being male, low level of education, living in rural area, and receiving general anesthesia were significantly associated with patients’ satisfaction on informed consent process. Surgeons and anesthesia professionals need to work more to improving the satisfaction of patients with preoperative informed consent process. Researchers are expected to do periodic assessment of patients’ level of satisfaction and factors affecting satisfaction.

Transplant donor consent and dual roles: A case study in ethical dilemmas

Transplant donor consent and dual roles: A case study in ethical dilemmas
Original Article
Gassas
Ethics, Medicine and Public Health, August 2022; 23
Abstract
Summary
Background
This case study describes the ethical dilemma encountered by a Bone Marrow Transplant (BMT) coordinator upon withdrawal of a donor’s consent. The case points to the pressure on the coordinator to advocate simultaneously for donor and patient, which results in conflict between the coordinator’s dual roles.
Objectives
The aim of this case study is to uncover neglected facts about ethical dilemmas concerning patient donors and transplant coordinators in Saudi Arabian settings.
Methods
This paper was developed from a case study involving the ethical issues reported here. The paper also explores potential solutions to such dilemmas, especially in centres without FACT-JACIE accreditation.
Conclusion/perspective
The risk of transplant coordinators’ pressuring potential donors to donate against their will is highly deserving of consideration because it is as dangerous as having the same physician treat patients and assess donors. Societal norms and pressures should be considered, particularly within Saudi Arabian culture, as they may lead to donations made without free and full consent. Health care providers may lose their ethical orientation in this context, especially in unaccredited hospitals or understaffed units. Creating a healthy donor programme is the key to safe practices that preserve donors’ rights, reduce pressure on primary teams and ensure application of international JACIE standards.

How Do Prescribing Clinicians Obtain Consent to Initiate Gender-Affirming Hormones?

How Do Prescribing Clinicians Obtain Consent to Initiate Gender-Affirming Hormones?
Gaines Blasdel, Avery Everhart, Colt St. Amand, Monica Gaddis, Frances Grimstad
Transgender Health, 21 June 2022
Abstract
Purpose
Multiple consent models exist for initiating gender-affirming hormone therapy (GAHT). Our study aim was to examine the variety of approaches utilized by clinicians.
Methods
Online and in-person recruitment of clinicians involved in gender-affirming care was undertaken from June 2019 through March 2020. Participants completed an online survey.
Results
Of the 175 respondents, 148 prescribed GAHT. Sixty-one (41.2%) prescribed to adults only, 11 (7.4%) to minors only, and 76 (51.4%) prescribed to adults and minors. Of those who prescribed to adults, more than half (n=74, 54.4%) utilized a written consent model, one-fourth only verbal consent (n=33, 24.3%), and one-fifth required an additional mental health assessment (MHA) (n=29, 21.3%). Of those prescribing to minors, most required either written consent (n=39, 44.8%) or an additional MHA (n=35, 40.2%). Only 11 (12.6%) utilized only verbal consent for minors. Rationales provided for requiring an additional MHA in adults included protection from litigation, lack of competence in assessing psychosocial readiness for GAHT, and believing that this is the best way to ensure the patient has processed the information. Practicing in multidisciplinary clinics was associated with not requiring an MHA for adult GAHT.
Conclusion
Clinicians across fields are utilizing different models to provide the same treatment, with varying rationales for the same model. As a result, patients receive nonstandard access to care despite similar clinical presentations. Our study highlights an important area for further improvement in GAHT care.

Informed consent prior to nursing care: Nurses’ use of information

Informed consent prior to nursing care: Nurses’ use of information
Research Article
Helen Aveyard, Abimola Kolawole, Pratima Gurung, Emma Cridland, Olga Kozlowska
Nursing Ethics, 20 June 2022
Abstract
Background
Informed consent prior to nursing care procedures is an established principle which acknowledges the right of the patient to authorise what is done to him or her; consent prior to nursing care should not be assumed. Nursing care procedures have the potential to be unwanted by the patient and hence require an appropriate form of authorisation that takes into consideration the relationship between the nurse and patient and the ongoing nature of care delivery.
Research question
How do nurses obtain consent from patients prior to nursing care?
Design
Critical incident technique and the collection of critical happenings.
Participants
17 participants who were all qualified nurses took part in in-depth interviews
Ethical considerations
Ethical approval was obtained from the university ethics committee.
Findings
Information giving is a key component prior to nursing care procedures. Nurses provide information to patients as a routine aspect of care delivery, and do so even when the patient is unable to communicate themselves. Whilst some participants described how information giving might be rushed or overlooked at times, it is clearly an established part of nursing care and is provided to ensure the patient knows what to expect when care is delivered. What is less clear is the extent to which information is given in order to seek the consent – rather than merely inform the patient – about nursing care.
Conclusion
Implied consent is often an appropriate way in which consent is obtained prior to nursing care procedures. It takes into account the ongoing care provision and the relationship that exists between the nurse and patient. However implied consent should not be assumed. Nurses need to ensure that information is given not only to inform the patient about a procedure but to enable the patient to give his or her consent and to find an alternative way forward if the patient withholds their consent.

Nocebo effects on informed consent within medical and psychological settings: A scoping review

Nocebo effects on informed consent within medical and psychological settings: A scoping review
Research Article
Nadine S. J. Stirling, Victoria M. E. Bridgland, Melanie K. T. Takarangi
Ethics & Behavior, 8 June 2022
Abstract
Warning research participants and patients about potential risks associated with participation/treatment is a fundamental part of consent. However, such risk warnings might cause negative expectations and subsequent nocebo effects (i.e., negative expectations cause negative outcomes) in participants. Because no existing review documents how past research has quantitatively examined nocebo effects – and negative expectations – arising from consent risk warnings, we conducted a pre-registered scoping review (N = 9). We identified several methodological issues across these studies, which in addition to mixed findings, limit conclusions about whether risk warnings cause nocebo effects.

Abandon Informed Consent in Favor of Probability-Based, Shared Decision-Making Following the Wishes of a Reasonable Person

Abandon Informed Consent in Favor of Probability-Based, Shared Decision-Making Following the Wishes of a Reasonable Person
Research Article
John T James
Journal of Patient Experience, 7 June 2022
Open Access
Abstract
Legally and ethically physicians must provide information to patients so they may make an informed decision about invasive procedures. The problem is who decides what information to provide. Is it the reasonable patient or the reasonable physician? Individual patients and individual physicians may differ from the norm on what is reasonable. This problem may be solved by shared decision-making in which the preferences of the patient and the probability-based knowledge of the physician are used to co-produce an optimal choice. Currently, patients are seldom prepared to engage in shared decision-making, and vestiges of meaningless “informed consent” are common. The present case study illustrates how “reasonable person” survey data may be used by a patient to engage in probability-based, shared decision-making with a surgeon planning to perform a laminectomy. Recommendations include probability-based, shared decision-making training for patients and physicians and improved documentation to facilitate learning.

Patient experience of informed consent for diagnostic coronary angiogram and follow-on treatments

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

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.