Consent in medical practice
H K Shreekrishna, Aruna B Rao
International Journal of Preclinical and Clinical Research, 4 June 2021
Open Access
Abstract
Consent is an expression of autonomy and represents the right of a patient to make a decision in a medical matter concerning him. Consent is not just a procedural formality but also a legal requirement. The process of informed consent occurs when communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention. In India, the number of suits against doctors is increasing because of failure to take informed consent or inadequate consent from patients for various procedures. Any examination of a patient by the doctor without his consent amounts to assault (351IPC). Ignorance of laws is not a defense in negligence cases, so every practicing doctor should be aware of their responsibilities about consent in medical practice. Consent is not an option but a necessity in medical practice.

Donor Factors Associated with Familial Consent for Organ Donation among Trauma Casualties: a 10-Year Retrospective Study
Naama Bursztyn, Tomer Arad, Tamar Fink, Jonathan Cohen, Michael Stein
The Israel Medical Association Journal, 23 May 2021; 23(5) pp 286-290
Open Access
Abstract
Background
Consent rates for organ donation remain one of the most important factors determining the number of organs available for transplantation. Trauma casualties constitute a substantial part of the deceased organ donor pool and have unique characteristics that distinguish them from the general donor population. However, this group has not been extensively studied.
Objectives
To identify donor factors associated with positive familial consent for solid organ donation among trauma casualties.
Methods
This retrospective study included all trauma casualties who were admitted to the Rabin Medical Center, Beilinson hospital, during the period from January 2008 to December 2017, who were potential organ donors. Data collected included demographic features, the nature of the injury, surgical interventions, and which organs were donated. Data was collected from the Rabin Medical Center Trauma Registry.
Results
During the study period 24,504 trauma patients were admitted and 556 died over their hospital course. Of these 76 were potential donors, of whom 32 became actual donors and donated their organs. Two factors showed a statistically significant correlation to donation, namely female gender (P = 0.018) and Jewish religion of the deceased (P = 0.032).
Conclusions
Only a small group of in hospital trauma deaths were potential solid organ donors (13.7%) and less than half of these became actual donors. Consent rates were higher when the deceased was female or Jewish.

Comparison of The Quality of Informed Consent in Angiography Patients in Selected ‎Hospitals in Mashhad from The Perspective of Patients and Physicians and Providing ‎Solutions
Original Article
N Atashdehghan, M Meraji, J Jamali, Mehdi Yousefi, S Fazaeli
Journal of Paramedical Sciences & Rehabilitation, 23 May 2021
Abstract
Purpose
Obtaining informed consent from patients, which is the basis of medical ethics and the most basic rights of patients, requires compliance with the conditions. The aim of this study was to compare the quality of informed consent of patients admitted to angiography in selected hospitals of Mashhad in 1398 from the perspective of patients and physicians.
Methods
This study has a descriptive-cross-sectional design. First, by examining the texts, the quality indicators of obtaining informed consent were extracted and a questionnaire for patients and physicians was compiled. Questionnaire was developed and validated to assess the views of patients and physicians in this field. Then, 10 doctors who had the most angiography in the selected hospitals of Imam Reza (AS) and Ghaem (AS), were randomly selected the questionnaire for doctors and 30 patients for each physician, and completed the questionnaire of the patients.
Results
Physicians ‘questionnaire with 11 questions and 4 dimensions and patients’ questionnaire with 22 questions and 6 dimensions were developed. The answers in each question were scored as a Likert scale from very low (1) to very high (5) and the average score of each dimension was determined. In evaluating the quality of informed consent, the highest score from the perspective of patients and physicians was related to the dimension of “physician-patient interaction”. The mean score was 2/94 in the evaluation of patients and 3/8 in the self-assessment of physicians. A significant relationship was found between the level of education of patients and the dimensions of understanding and volunteering (p ≤0/05). Informed consents were obtained before the day of admission to the treating physician and after providing the necessary explanations by the physician, effective communication training workshop for residents and physicians and explaining the legal, religious, therapeutic aspects, etc. Delfi was emphasized.
Conclusion
In all respects, the score of the patient’s evaluation was less than the desired level also lower than the score of the physicians’ self-assessment. It is suggested that the proposed solutions be used in the way of obtaining satisfaction.

The Relation Between Patient Education and Doctors’ Compliance on Informed Consent Implementation
Roshynta Linggar Andatu, Arlina Dewi
Turkish Journal of Physiotherapy and Rehabilitation; 20 March 2021; 32(3)
Open Access
Abstract
Introduction
Informed consent is a patient’s right and doctor’s obligation to explain the patient’s condition and disease to obtain medical approval. Doctors do not fully provide the information and explanation. Research conducted on informed consent patients showed 77.3% of respondents did not understand medical terms and explanations about the informed consent. The lack of knowledge from patients or families can lead to malpractice suits if there is a problem in administering medical treatment. Purpose
to determine patient education’s impact on doctors’ compliance in implementing informed consent.
Method
Quantitative research with pre-experimental research design (one group pre and post-test design). The research subjects were doctors who gave informed consent. The research object is patients or families who received informed consent. Researcher did the pre test by asking the patient or family about the content of informed consent whether they can answer or not and explained after all the questions had given that they had the right to know what they should know for the invasive procedure. Patient or family had the opportunity to ask the doctor some hours before invasive procedure. Then, researcher came back to evaluate the understanding of patient and family about the procedure by asking the same questions. The study was conducted for 3 (three) months, March – May 2020 on 30 patients or their families. The data analysis used Mann Whitney test to determine how significant the difference between two populations was taken from the same population. This research instrument used a structured interview checklist based on regulation of the Minister of Health of the Republic of Indonesia 290 / MENKES / PER / III / 2008 concerning Approval of Medical Actions and the Law on Medical Practice Article 45 of 2004.
Result
Pre-test showed that 83% of respondents know the doctor’s name in charge, 63% of the diagnosis, 43% of the procedure’s aim, and 3% of the prognosis. 50% of patients cited 2 points of informed consent, and 3.33% mentioned 4 points. In the post-test, 100% of respondents mentioned the doctor’s name, the diagnosis, the purpose of the procedure, and when the patient’s condition monitors, 73.33% of respondents mentioned 8 points of informed consent, 3.33% were able to mention 9 points. Mann Whitney test showed the following results (p = 0.000).
Conclusion
Education to patients or families improve doctors’ compliance in implementing informed consent.

Consent for blood transfusion: summary of recommendations from the Advisory Committee for the Safety of Blood, Tissues and Organs (SaBTO)
Michael F Murphy, Andrea Harris, James Neuberger
Clinical Medicine Journal, 17 May 2021
Abstract
The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) decided that its 2011 recommendations on consent for blood transfusion needed to be reviewed and revised due to evidence of poor compliance and recent legal guidance on consent. The recommendations are to ensure that patients are informed about and understand the purpose, benefits and potential risks of transfusion, and have an opportunity to discuss their treatment options. They should be incorporated into local practices for all patients.

The effectiveness of handout assisted versus verbal consent on post-operative recall and understanding – A randomized control study
Jun Kit Koong, Retnagowri Rajandram, Naveendran Sidambram, Vairavan Narayana
The Surgeon, 8 May 2021
Abstract
Background
Consent is an important component of surgical care. Poorly attempted consent bears significant ethical and legal implications. We assessed the effectiveness of handouts in improving postoperative consent understanding and recall compared to standard verbal consent during laparoscopic cholecystectomy as a tool that may improve information retention and leads to better treatment satisfaction.
Methods
This is a prospective block randomized, non-blinded study conducted at a single tertiary hospital. Patients undergoing elective laparoscopic cholecystectomy between August 2017 and October 2018 were recruited and randomized into Handout Assisted Consent (HC) and Verbal Consent (VC) group. The HC group was given an adjunct handout on laparoscopic cholecystectomy during consent process in addition to the standard verbal consent. A validated open-ended verbal understanding and recall questionnaire was administered to all patients in both groups at Day 1, 30 and 90 after surgery. Patient satisfaction of the consent process was evaluated with Likert scale.
Results
A total of 79 patients were enrolled, 41 patients and 38 patients in VC and HC groups respectively. Level of understanding among patients were equal and consistent across time in both groups (P > 0.05). There was significant decline (P < 0.0001) for both groups in ability to recall information between Day 1 to Day 30 and Day 30 to Day 90. A slightly higher satisfaction rate was found among patients that received HC (P > 0.05).
Conclusion
There is good consistent understanding of the surgery in both groups. However, recall of specific surgical consent items decreased significantly over time in both groups. Handouts may have increased satisfaction among patients but did not improve recall in this preliminary study.

Psychotropic Medication Informed Consent: A Cross-Specialty Role-Playing Skill Builder
Emily Diana, Derrick Hamaoka, Matthew Goldenberg, Kelly L. Cozza
MedEdPORTAL, 5 May 2021; 17(11)
Open Access
Abstract
Introduction
Obtaining informed consent (IC) is an essential medical practice. Utilization of IC role-playing training with medication study cards and self-peer-supervisor review should improve student fund of knowledge and strengthen IC skills for clerkship-level medical students.
Methods
Between 2017 and 2020, approximately 555 clerkship medical students used our formative role-playing exercise tools. Students independently prepared psychotropic medication study cards and role-played IC during group didactics. Peer and supervisor reviews were not recorded but were discussed as a group. Students completed routine anonymous post clerkship surveys regarding the IC exercise. An enhanced IC curriculum was deployed in 2020, adding a training video and peer/supervisor feedback form. Student feedback and specialty shelf exam scores were reviewed to assess the exercise’s effectiveness.
Results
Surveys indicated satisfaction with the exercise and increased confidence in obtaining IC. Interestingly, the student group that received enhanced IC training had fewer shelf exam failures than those without, perhaps indicating improved fund of psychotropic medication knowledge.
Discussion
Peer role-playing IC training is well accepted by students, allows practice of essential elements of IC and shared decision-making, and provides an engaging way to improve medication fund of knowledge. Our clerkship has initiated development of an IC objective structured clinical examination station and is adapting the exercise across specialties for longitudinal learning in response to the positive feedback and ease of use. Structured review of psychotropics and peer IC role-playing can be tailored for other specialties, medications, and procedures and further developed for use in pre- and postclerkship education.

Editor’s note: MedEdPORTAL is the Association of American Medical Colleges journal of teaching and learning resources.

Reaudit and Completing the Audit Cycle of Quality of Informed Consent for Surgery on Neck of Femur Fracture in Royal Stoke University Hospital
T Khaleeq, U Hanif, Y Maqsood, K Ahmed, A Patel
British Journal of Surgery, 4 May 2021; 108(Supplement 2)
Abstract
Using guidelines highlighted by the British Orthopaedic Association an reaudit was performed within our department to assess the adequacy of informed consent for NOF fractures to complete the audit cycle. 50 patients were included in the Audit and reaudit. Risk was classified as common, less common, rare and ‘other’. The adequacy of informed consent was evaluated by assessing the quality and accuracy of documentation. Infection, bleeding risks, clots and anaesthetic risks were documented in all patients (100%). Areas of improvement were seen in the documentation of neurovascular injuries (98%), pain (90%) and altered wound healing (87%). There was no significant change in the documentation of failure of surgery (83%) and neurovascular injuries (98%). The Poorly documented risk factors from the initial audit were seen to improve which included mortality (70%), prosthetic dislocation (90%) and limb length discrepancy (50%). There has been a significant improvement in the quality of Informed consent in the department and this could be attributed to the installation of ward posters and verbal dissemination of information to junior doctors. Recommendation for interventions would be to present in the next clinical governance meeting and presenting at the new junior doctors’ induction at August.

The Value of a Support Person During the Surgical Consent Process: A Prospective Cohort Study
Elisabeth C. Sappenfield, David M. O’Sullivan, Adam C. Steinberg
Female Pelvic Medicine & Reconstructive Surgery, 12 April 2021
Abstract
Objective
The objective of this study is to investigate the impact of support person participation during the preoperative appointment.
Methods
This is a prospective cohort study involving patients scheduled to undergo pelvic reconstructive surgery. Eligible patients were enrolled at the preoperative appointment and compared by presence or absence of a support person. Questionnaires were completed before and after the preoperative appointment, 1–3 days before surgery, and at the postoperative appointment. Previsit questionnaires included the Generalized Anxiety Disorder-7, 6-item short form of the Spielberger State-Trait Anxiety Inventory (STAI-6), and Brief Health Literacy screen. Postvisit questionnaires included the STAI-6, satisfaction with decision scale for pelvic floor disorders, preoperative preparedness questionnaire, and knowledge questionnaire. At the postoperative appointment, participants completed the patient global impression of improvement and postoperative symptom and satisfaction questionnaire. Primary outcome was patient anxiety measured by the STAI-6.
Results
Seventy-six patients participated in the study: 37 were categorized in the support person cohort and 39 were categorized in the no support person cohort. The mean scores of the STAI-6 did not differ between the support person and no support person cohorts at all time points (previsit: 42.97 ± 13.23 vs 41.53 ± 17.11, P = 0.68; postvisit: 38.11 ± 12.76 vs 36.33 ± 11.72, P = 0.53, and 1–3 days before surgery: 42.61 ± 13.0 vs 41.05 ± 16.39, P = 0.65). Overall preparedness, satisfaction with decision scale for pelvic floor disorders, and knowledge questionnaire did not differ between cohorts at both time points. Perioperative phone calls were similar between cohorts.
Conclusion
Our study suggests that the presence of a support person at preoperative counseling for pelvic floor surgery should be a personal preference and not a recommendation.

The use of bovine pericardial patches in vascular surgery: where do we draw the line in obtaining informed consent?
Stacie Hodge, Nicholas Greaves, David Murray
Annals of Vascular Surgery, 24 April 2021
Abstract
With advances in modern medicine there has been unprecedented growth in biological materials derived from either porcine or bovine products. Absolute or relative restrictions of the dietary consumption of bovine or porcine products among different religious groups are relatively well documented. However, there are no clear guidelines about the non-dietary use of animal products for patients with particular secular or religious beliefs. For a patient undergoing a carotid endarterectomy, induction with propofol, administration of heparin at the time of vessel clamping, use of a bovine pericardial patch for angioplasty, covering the wound with a hydrocolloid dressing and post-operative aspirin administration exposes the patient to animal products at every stage, from the moment they walk through the door. A number of articles have advocated obtaining informed consent when using animal products in healthcare but where should the line be drawn? In particular, should we consent for the use of bovine pericardium in vascular surgery? This paper reviews the evidence available and discusses our current standpoint from both a legal and ethical aspect.