Adequacy of measures of informed consent in medical practice: A systematic review
Research Article
Kerry A. Sherman, Christopher Jon Kilby, Melissa Pehlivan, Brittany Smith
PLoS One, 27 May 2021
Open Access
Abstract
As a critical component of medical practice, it is alarming that patient informed consent does not always reflect (1) adequate information provision, (2) comprehension of provided information, and (3) a voluntary decision. Consequences of poor informed consent include low patient satisfaction, compromised treatment adherence, and litigation against medical practitioners. To ensure a well-informed, well-comprehended, and voluntary consent process, the objective and replicable measurement of these domains via psychometrically sound self-report measures is critical. This systematic review aimed to evaluate the adequacy of existing measures in terms of the extent to which they assess the three domains of informed consent, are psychometrically sound and acceptable for use by patients. Extensive searching of multiple databases (PsychINFO, PubMed, Sociological Abstracts, CINAHL, AMED) yielded 10,000 potential studies, with 16 relevant scales identified. No existing scale was found to measure all three consent domains, with most only narrowly assessing aspects of any one domain. Information provision was the most frequently assessed domain, followed by comprehension, and then voluntariness. None of the identified scales were found to have adequate evidence for either high quality psychometric properties or patient user acceptability. No existing scale is fit for purpose in comprehensively assessing all domains of informed consent. In the absence of any existing measure meeting the necessary criteria relating to information, comprehension and voluntariness, there is an urgent need for a new measure of medical consent to be developed that is psychometrically sound, spans all three domains and is acceptable to patients and clinicians alike. These findings provide the impetus and justification for the redesign of the informed consent process, with the aim to provide a robust, reliable and replicable process that will in turn improve the quality of the patient experience and care provided.

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.