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
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
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.