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.
Month: July 2022
Animal-informed consent: sled dog tours as asymmetric agential events
Animal-informed consent: sled dog tours as asymmetric agential events
David A. Fennell
Tourism Management, December 2022; 93
Abstract
Standing in the way of a stronger voice for animals used in tourism is Cartesian and contractarian thinking on the part of operators and ontologically and epistemically constructed barriers by theorists. This paper pushes the animal ethics agenda forward by developing a novel, first-of-its-kind animal-informed consent framework in tourism under the assumption that sled dogs do, in fact, consent or deny consent through their emotions, preferences, behaviours, and physical state. The Five Domains model of animal welfare focused on the subjective experiences of animals is used to build the framework. The discussion culminates with a discussion on asymmetric agency, which speaks to the lack of balance between human and animal agents working in the same events.
Mapping consent practices for outpatient psychiatric use of ketamine
Mapping consent practices for outpatient psychiatric use of ketamine
David S. Mathai, Scott M. Lee, Victoria Mora, Kelley C. O’Donnell, Albert Garcia-Romeu, Eric A. Storch
Journal of Affective Disorders, 1 September 2022; 312, pp 113-121
Abstract
Background
Given increasing community-based and off-label use of ketamine for psychiatric indications, we examined current informed consent processes from a convenience sample of outpatient ketamine clinics to identify areas of congruence with current evidence and opportunities for growth.
Methods
Using a rubric developed from existing practice guidelines, we conducted an exploratory analysis of informed consent documents (IC-Docs) from 23 American clinics offering ketamine as a psychiatric treatment. Domains assessed included clinical content, procedures, and syntax.
Results
Participating clinics (23/288) varied widely in their constitution, training, and services provided. We found that IC-Docs addressed a majority of consent elements, though did so variably on an item-level. Areas for improvement included communication around long-term adverse effects, treatment alternatives, medical/psychiatric evaluation prior to treatment, medical/psychological support during treatment, adjunctive psychological interventions, and subjective/dissociative-type effects. All forms were limited by poor readability.
Limitations
Our study was limited by convenience sampling along with possible underestimation of verbal consent processes.
Conclusions
As ketamine continues to emerge as a psychiatric intervention, both patients and providers will benefit from a deliberate consent process informed by scientific, ethical, and pragmatic factors toward the goal of shared decision-making regarding treatment.
Comparing shared decision making using a paper and digital consent process. A multi-site, single centre study in a trauma and orthopaedic department
Comparing shared decision making using a paper and digital consent process. A multi-site, single centre study in a trauma and orthopaedic department
Rory Dyke, Edward St-John, Hemina Shah, Joseph Walker, Dafydd Loughran, Raymond Anakwe, Dinesh Nathwani
The Surgeon, 11 June 2022
Abstract
Introduction
The importance of shared decision making (SDM) for informed consent has been emphasised in the updated regulatory guidelines. Errors of completion, legibility and omission have been associated with paper-based consent forms. We introduced a digital consent process and compared it against a paper-based process for quality and patient reported involvement in shared decision making.
Methods
223 patients were included in this multi-site, single centre study. Patient consent documentation was by either a paper consent form or the Concentric digital consent platform. Consent forms were assessed for errors of legibility, completion and accuracy of content. Core risks for 20 orthopaedic operations were pre-defined by a Delphi round of experts and forms analysed for omission of these risks. SDM was determined via the ‘collaboRATE Top Score’, a validated measure for gold-standard SDM.
Results
72% (n = 78/109) of paper consent forms contained ≥1 error compared to 0% (n = 0/114) of digital forms (P < 0.0001). Core risks were unintentionally omitted in 63% (n = 68/109) of paper-forms compared to less than 2% (n = 2/114) of digital consent forms (P < 0.0001). 72% (n = 82/114) of patients giving consent digitally reported gold-standard SDM compared to 28% (n = 31/109) with paper consent (P < 0.001).
Conclusion
Implementation of a digital consent process has been shown to reduce both error rate and the omission of core risks on consent forms whilst increasing the quality of SDM. This novel finding suggests that using digital consent can improve both the quality of informed consent and the patient experience of SDM.