PURPOSE: This study identifies best practices for informed consent for emergent computed tomography (CT) scans and development of a new document used to explain the informed consent using an iPad in an emergency department (ED). METHODS: Literature review, semi-structured interviews, and observations of informed consent were used for development of a new process for informed consent. Participants were ED physicians, residents, and senior nurses. Interviews were conducted for identification of agreed best practice and to derive new structural documents for classification of the information into relevant sections. RESULTS: Interviews identified a variety of perceived current deficits in informed consent, including difficult contents and missing explanation of the possible adverse events, such as radiation hazards. Participants provided examples of poor informed consent that were thought to have led to patient dissatisfaction; these included delay for patients who do not agree to undergo CT scan due to brief or inaccurate explanation. The interviewers' responses were used to reach a unifying 'best practice' for the content of informed consent. Their opinions were also used in implementation of a new tool for informed consent using the iPad. CONCLUSION: A new informed consent was developed using an iPad in order to provide a more efficient and organized template, which includes visual information necessary to facilitate understanding. Additional video clips were also developed in order to provide adjuvant materials for detailed explanations.
Consent Forms ; Emergencies ; Humans ; Informed Consent ; Practice Guidelines as Topic

BACKGROUND/AIMS: Given that the use of chemotherapy has increased, together with the incidence of cancer, the importance of patient autonomy in decision-making is being emphasized. This study aimed to promote understanding of informed consent by analyzing doctors' perceptions of, and conduct during, the acquisition of written informed consent before chemotherapy. METHODS: Forty-eight doctors directing or performing chemotherapy were surveyed in August 2009. In addition, the electronic medical records of patients who underwent chemotherapy between August 1, 2008, and August 31, 2009, were reviewed retrospectively. RESULTS: All 48 respondents replied that acquiring informed consent was necessary before chemotherapy, but only 27 (56.3%) were aware of the format of the consent that had been obtained. Regarding the format of informed consent, 34 (70.8%) felt that it should be brief and 21 (43.8%) indicated that the time they spent in acquiring informed consent ranged from 10 to 14 minutes. Reviewing actual performance in acquiring informed consent, only 22 (15.6%) out of 141 patients who underwent chemotherapy had written informed consent documents in their electronic medical records. CONCLUSIONS: To properly acquire informed consent for chemotherapy, its meaning and importance must be understood by both physicians and patients. Moreover, patients need a standardized format of appropriate length for informed consent, with easily understood terms.
Comprehension ; Consent Forms ; Surveys and Questionnaires ; Electronic Health Records ; Electronics ; Electrons ; Humans ; Incidence ; Informed Consent ; Retrospective Studies

An informed consent is a document signed by the patient or the patient's legal guardian(s) that signifies the acceptance that the patient will undertake a specific medical treatment suggested and explained by the health care provider(s). Recently, there have been an increasing number of circumstances where obtaining an informed consent is mandatory. However, a standard form and required content of the informed consent, as well as laws, regulations, and analyses regarding the concept of informed consent are not available. This article introduces an observation of the legal force of informed consent forms that are used in practice, and of the legal issues in connection with them.
Consent Forms ; Delivery of Health Care ; Humans ; Informed Consent* ; Jurisprudence ; Medical Records ; Social Control, Formal

BACKGROUND: The decision on whether or not to transfuse should be based on agreement from the patient's own understanding and free will. In Korea, the transfusion guideline first developed in 2009 specified that informed consent should be obtained before transfusion. The standard consent form has also been distributed since 2010. The purpose of this study was to evaluate the degree of improvement in obtaining informed consent for blood transfusion. METHODS: Prior to the development of the transfusion guideline in 2008, an e-mail survey was conducted on 105 clinicians. In 2015, questionnaires were sent to 1,179 clinicians, 32 academic societies, and 6 institutions. RESULTS: Forty-three and 374 answers were received in 2008 and 2015, respectively (response rate, 41.0% and 30.7%). Compared with 2008, the use of explanatory materials increased from 20.9% to 70.5%, and consent acquisitions using a written form increased from 27.9% to 81.7%. The number of respondents who answered that informed consent for transfusions is absolutely necessary also increased from 51.2% to 71.3%. Among the reasons why obtaining informed consent for transfusion can be difficult, the response that standardized consent form is unavailable decreased from 51.2% to 26.9%. CONCLUSION: The transfusion guideline and the standard consent form have contributed greatly to the improvement of obtaining informed consent before blood transfusion at medical institutions in Korea.
Blood Transfusion* ; Consent Forms ; Electronic Mail ; Informed Consent* ; Korea ; Personal Autonomy ; Surveys and Questionnaires

BACKGROUND: As the problems of medical malpractices become a very serious social issue, it is necessary to increasingly relate law to medical practice and evaluate medical services. However, it is not easy to legally call someone to account, as medical services are highly specific, especially anesthetic management. Anesthesiologist can expect to be involved in legal action alleging malpractice, either as a defendant or expert witness. METHODS: The anesthetic informed consent form was examined at 42 general hospitals in the Republic of Korea. The chief physician of the department of anesthesiology and pain medicine was asked for the anesthetic informed consent form they used in clinical anesthetic practice, and then what constitutes adequate informed consent analyzed. RESULTS: All of the hospitals were using informed consent forms, but 42.9% of the hospital used a specific form to describe the complications or risks associated with anesthetic management. In 71.4% of hospitals, the anesthesiologists or anesthetic residents explained the anesthetic risk, but 28.6% of hospitals the anesthetic complications were explained by nurses or surgeons. In 76.2% of hospitals, the anesthetic risks were explained to both the patients and parents, but in 23.8% these were explained to parents only. CONCLUSIONS: We propose a new anesthetic informed consent form for adequate explanation and agreement to legal requirements.
Anesthesiology ; Consent Forms ; Expert Testimony ; Hospitals, General ; Humans ; Informed Consent* ; Jurisprudence ; Malpractice ; Parents ; Republic of Korea

BACKGROUND: The autonomy of patient is becoming more important in medical fields and in transfusion as well. In Korea, there is not yet any legal regulations or reports concerned with informed consent for transfusion. METHODS: Questionnaires were e-mailed to 202 doctors. Among them, 105 doctors received the e-mail questionnaire and 43 (41%) replied. RESULTS: Forty one respondents (95.3%) replied that informed consent for transfusion is necessary. Thirty nine (90.7%) replied that they explain something about transfusion to the patient. The given information during explanation are benefits, adverse reactions, and risks if transfusion not to be given, in decreasing order. Eighteen (42.0%) replied that consent is documented. The reasons for the difficulty in getting informed consent were replied to be unavailability of standardized consent forms, explanation materials, and lack of time. CONCLUSION: Korean doctors seem to agree that informed consent is necessary for transfusion but have difficulties in obtaining. Standardized consent forms and explanation materials will be helpful for its wide implementation.
Consent Forms ; Surveys and Questionnaires ; Electronic Mail ; Humans ; Informed Consent ; Korea ; Social Control, Formal

PURPOSE: This was a cross-sectional study designed to evaluate the subjective understanding of technical terms and contents of the informed consent forms given to patients about to undergo conscious sedative upper gastrointestinal endoscopy. METHODS: A group of conveniently selected 180 patients, who were undergoing sedative endoscopy were recruited in the endoscopy procedure room in a tertiary hospital from June to July 2011. Data were collected with a structured questionnaire. RESULTS: The average number of terms exposed was 8.12 out of 10 items, the average number of terms understood well by the patients was 5.53 out of 10 items, and the average number of right answers was 3.30 out of 5 items, and the percent of correct answers ranged from 26.1% to 90.0%. The exposure to terms differed by gender, education, and previous exposure to sedative endoscopy procedures. The number of "understanding of the terms well" responses differed according to age and previous exposure to sedative endoscopy procedures, and the correct answer rate was differed by education. CONCLUSION: The understanding of the terms and knowledge about the procedures were disappointing. Therefore, sufficient explanations should be provided to the patients. While the informed consent was taken by doctors, the level of understanding should be monitored by nurses. In particular, subjects who did not have any previous experience with endoscopy procedures showed relatively lower level of understanding. We recommend that medical terms should be replaced with more common and nontechnical words in consent forms.
Comprehension ; Consent Forms ; Cross-Sectional Studies ; Endoscopy ; Endoscopy, Gastrointestinal ; Humans ; Informed Consent ; Tertiary Care Centers

BACKGROUND: This study was conducted to standardize the written informed consent form for transfusion to establish the recipient's self-determination and safe blood transfusion procedures of hospitals. This survey focused on doctors' acknowledgment on informed consent before conducting a transfusion and its current situation. METHODS: Data collection was conducted in 11 tertiary hospitals from February 2010 to March 2010 with random sampling among the 30 hospitals that have a blood transfusion committee. The survey was carried out in the division of medical services that supports blood transfusion or in the blood transfusion committee of each hospital. The questionnaires focused on the necessity of written consent and its contents before transfusion. Also, informed consent forms were collected when a hospital already had an informed content form. RESULTS: The majority of hospitals (94.9%) agreed about the necessity of informed consent. However, only 6.7% of hospitals were obtaining informed consent before transfusion. The contents of the written form were the necessity of blood transfusion (94.9%), the adverse effects of transfusion (84.1%) and beneficiary of the transfusion (64.6%). Twenty-eight point two percent of the medical institutions were obtaining informed written consent forms and keeping them in the medical records. The problems for obtaining informed consent before a transfusion was insufficient standardized forms (40.4%) and a lack of time (33.9%). CONCLUSION: Though doctors agreed to the provision of information through consent forms, there were no standardized procedures and forms. Therefore, this study introduced the written form to medical institutions and academies. Also, it was applied to hospitals as an evaluation index in 2010. The written informed consent form can contribute to the safety of blood transfusions in the medical area.
Academies and Institutes ; Blood Transfusion ; Consent Forms ; Data Collection ; Informed Consent ; Korea ; Medical Records ; Tertiary Care Centers ; Surveys and Questionnaires

Consent is defined as the “voluntary agreement to or acquiescence in what another person proposes or desires”. In the context of medical practice it is now universally accepted that every human being of adult years and of sound mind has the right to determine what shall be done with his or her own body. Informed consent is now a central part of medical ethics and medical law. There has been a change in the public’s expectations of their role in medical decision making. The paternalistic approach by doctors is no longer acceptable. Today the patient has the right to receive and the doctor the obligation to give sufficient and appropriate information so that the patient can make an informed decision to accept or refuse a treatment option. This has led to higher standards of practice in the process of informed consent taking. Consent taking is both a legal and moral requirement. Failure to comply with standards of practice can result in criminal prosecution, civil litigation or disciplinary action by the relevant professional authority. Consent taking is a process and not merely a one-off affixation of the patient’s signature on a consent form. It involves a continuous discussion to reflect the evolving nature of treatment from before the treatment is given to the post-operative or discharge period. The regulatory authorities in many countries have established standards for consent taking which would include the capacity of the patient, the person who should seek consent, the information to be provided and the necessary documentation.
Informed Consent

PURPOSE: Informed consent is a basic right of patients undergoing medical procedures, but the effect of the type of consent form on the risk of invasive procedures is controversial, and the recall of information by patients has been poor. This trial was designed to assess the effect of video-assisted information on verbal informed consent to allow central venous catheter (CVC) insertion in the emergency department. METHODS: A prospective, randomized controlled trial was done on adult emergency department patients undergoing CVC insertion. Patients were randomized to the intervention or the control group. The intervention group had consent obtained with the assistance of video information (video group). The control group received a conventional education process that was conducted by the physician (verbal group) regarding indications, risks, and treatment of complications due to the procedure. Outcome variables consisted of an anxiety score, heart rate, and systolic and diastolic blood pressure at baseline and immediately after informed consent. All participants completed a 5-question knowledge measurement and graded their satisfaction level after the explanation. RESULTS: Of 208 patients enrolled, nine withdrew, leaving 199 for analysis (video n=99; verbal n=100). The two groups were similar with regard to their baseline characteristics. The video group was significantly less anxious after informed consent (4.5+/-0.8 vs 5.8+/-1.0, p=0.029) and had a significantly lower heart rate (64+/-12 vs 73+/-10, p=0.027). Mean knowledge scores were higher in the video group (3.82+/-0.55) compared to the verbal group (2.94+/- 0.75) (p=0.01). Satisfaction regarding the information received was higher in the video group (4.09+/-1.08) than in the verbal group (3.15+/-1.04) (p=0.00). CONCLUSION: Video-assisted informed consent decreases anxiety and improves satisfaction scales in patients undergoing CVC insertion. The Video group showed better recall of information compared with the verbal group.
Adult ; Anxiety ; Blood Pressure ; Catheterization, Central Venous ; Central Venous Catheters ; Consent Forms ; Emergencies ; Heart Rate ; Humans ; Informed Consent ; Mental Recall ; Patient Education as Topic ; Prospective Studies ; Weights and Measures