Informed consent for total knee arthroplasty: exploration of patient`s information acquisition and decision-making processes—a qualitative study
Research Article
Sandro Zacher, Julia Lauberger, Carolin Thiel, Julia Lühnen, Anke Steckelberg
BMC Health Services, 11 September 2023; 23(978)
Open Access
Abstract
Background
Total knee arthroplasty (TKA) is an option for the treatment of knee osteoarthritis (OA). Patients have high expectations regarding the benefits of the actual operation. Patients can seek a second opinion on the indication for TKA. In a study, less than half of recommended TKAs were confirmed by the second opinion and conservative treatments are not fully utilized. Informed consent forms that are used in Germany usually do not meet the requirements to support informed decision-making. Our aim was to describe the process from the diagnosis of knee OA through the decision-making process to the informed consent process for TKA, and to understand when, how, and by whom decisions are made. Moreover, we wanted to describe patients’ information needs and preferences about knee OA and its treatment, including TKA, and find out what information is provided. We also wanted to find out what information was important for decision-making and identify barriers and facilitators for the optimal use of evidence-based informed consent forms in practice.
Methods
We chose a qualitative approach and conducted semi-structured interviews with patients who were going to receive, have received, or have declined TKA, and with general practitioners (GP), office-based as well as orthopaedists and anaesthesiologists in clinics who obtain informed consent. The interviews were audio-recorded, transcribed and analysed using qualitative content analysis.
Results
We conducted interviews with 13 patients, three GPs, four office-based orthopaedists and seven doctors in clinics who had obtained informed consent. Information needs were modelled on subjective disease theory and information conveyed by the doctors. Patients in this sample predominantly made their decisions without having received sufficient information. Trust in doctors and experiences seemed to be more relevant in this sample than fact-based information. Office-based (GPs, orthopaedists) and orthopaedists in clinics had different understandings of their roles and expectations in terms of providing information.
Conclusions
We were able to identify structural barriers and assumptions that hinder the implementation of evidence-based informed consent forms.

Optimizing Informed Consent Discussions: Developing a Narrative for Transfusion Consent
Michelle P. Zeller, Marissa Laureano, Aditi Khandelwal, Shannon J. Lane, Richard Haspel, Mark Fung
Transfusion Medicine Reviews, 9 September 2023
Abstract
    Ensuring patient informed consent is a key tenet of modern medicine. Although transfusion of blood products is among the most common medical procedures performed in hospitalized patients, there is evidence that informed consent for transfusion is at times incomplete, poorly understood, hurried and/or inaccurate. This study aimed to develop a narrative that can be used as a framework for practicing physicians and for educational purposes to optimize the process for obtaining informed consent for blood transfusion.

The narrative was developed using a modified-Delphi approach with 5 Rounds that included feedback from Transfusion Medicine (TM) experts, transfusion-provider physicians and lay people. The surveys collected qualitative and quantitative data analyzed using thematic content analysis and descriptive statistics, respectively. Results from Round 1 and 2 generated a draft narrative and rounds 3 to 5 informed further modifications.

Round 1 included draft narrative scripts from 28 TM experts; thematic coding generated 97 topics. In round 2, 22/28 of the initial experts rated items identified from Round 1. Those with a Content Validity Index (CVI) ≥ 0.8 were used by the authors to develop a narrative. In Round 3, 20/24 participants from Round 2 reviewed the narrative with 100% agreeing on the items included and 90% agreeing the flow was logical. In Round 4, 23 transfusion prescribers (non-TM physicians) reviewed the narrative for flow, manner, length and usability; there was 83% agreement with non-exclusion of important topics; 91% felt it would be effective for teaching trainees. Round 5 included 24 non-medical lay people of different demographics. Most participants (92%) thought that the script was appropriate in length and there were opportunities to ask questions. Participants could also identify the adverse transfusion reactions and understood that they could refuse the transfusion. A narrative for obtaining informed consent for blood transfusion was created through multiple rigorous iterations of review and feedback with both transfusion providers and the lay public. The narrative, developed for a specific clinical scenario, was well-received by medical and non-medical participants and can be used, and modified, to help ensure patients understand the risks and benefits of blood transfusion.

Minimum standard assessment of informed consent for internal medicine transition to residency program: A cohort study
Mannat Marwaha, Raman Bhalla, Shivani Rao, Catherine Chen
Health Science Reports, 10 August 2023
Abstract
Background and Aims
Interns must be proficient in obtaining informed consent (IC), which is the Association of American Medical College’s 11th of 13 Entrustable Professional Activities (EPAs). Medical students have limited opportunity to practice IC during clerkships, resulting in inconsistent proficiency. We aimed to create a tool to assess whether our transition to residency (TTR) workshop enables fourth‐year medical students to meet a minimum standard of obtaining IC.
Methods
Sixty fourth‐year medical students were enrolled in the internal medicine virtual TTR course during AY2021. The curriculum prioritizes deliberate practice activities. Pre‐ and postworkshop assignments involved students typing verbatim what they would say during IC encounters. We modified an IC abstraction tool created by Spatz et al. to assess a minimum standard for students’ IC assignments. Our final 7‐item tool consisted of the following domains: “What,” “Why,” “How,” “Benefits,” “Quantitative Risks,” “Qualitative Risks,” and “Alternatives,” weighing 1 point each. A minimum standard was obtained with a score of 6 or more points by appropriately discussing at least one domain involving risk and all other domains.
Results
Students scored highly on the prework domains pertaining to “What,” “Why,” and “How” of the procedure with no significant difference on postwork. Significant improvement was achieved on postwork domains covering “Benefits” (p = 0.039) and “Alternatives” (p = 0.031). For domains involving “Qualitative” and “Quantitative Risks,” there were no statistically significant improvements from pre‐ to postwork scores. Fifteen and 22 students met the minimum standard for IC on pre‐ and postwork, respectively.
Conclusion
Our students demonstrated a good a priori understanding of the “What,” “Why,” and “How” domains. After the workshop, they more reliably discussed “Benefits” and “Alternatives.” Our abstraction tool helped assess the strengths and weaknesses in our students’ IC skillset and helped recognize areas of our curriculum that will benefit from improvements to bring students to meet the minimum standard.