Informed consent and the gastrointestinal endoscopist

doi:10.1016/S0016-5107(85)72051-2

Gastrointestinal Endoscopy

Volume 31, Issue 3, June 1985, Pages 218-221

https://doi.org/10.1016/S0016-5107(85)72051-2 Get rights and content

The gastrointestinal endoscopist should be familiar with the Doctrine of Informed Consent. Although the concept is difficult to apply clinically, a reasonable approach is presented to the endoscopist. The ultimate goals of informed consent are shared decision making and self-determination, but it is important that the endoscopist also consider the potential legal liability when obtaining informed consent.

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Cited by (17)

Informed consent in colonoscopy: A comparative analysis of 2 methods
2015, Revista de Gastroenterologia de Mexico
La forma de obtener el consentimiento informado es variable, por lo que el objetivo de este trabajo fue evaluar el nivel de conocimientos sobre la colonoscopia comparando 2 modalidades de consentimiento.
Estudio observacional, transversal y comparativo realizado en pacientes sometidos a colonoscopia en un hospital público (grupo A) y en un hospital privado (grupo B). El grupo A recibió información verbal por un médico e impresa y el grupo B solo impresa. Una o 2 semanas después se realizó una encuesta telefónica.
Se incluyó a 176 sujetos (grupo A n = 55 y grupo B n = 121). El 69.88% (n = 123) de los pacientes tenían nivel educativo universitario, el 23.29% (n = 41) nivel educativo secundario, el 5.68% (n = 10) nivel educativo primario completo y los restantes (n = 2) no habían completado estudios. El 100% conocía las características y el 99.43% los beneficios del procedimiento. El 97.7% recibió información sobre complicaciones, el 93.7% nombró alguna y el 25% (n = 44) recordó complicaciones mayores. Todos respondieron, recibieron y leyeron el consentimiento informado antes del estudio. No hubo diferencias entre los grupos en el conocimiento de las características, los beneficios, la recepción y la lectura del consentimiento. El grupo B respondió mejor sobre las complicaciones (p = 0.0027) y el grupo A recordaba más las complicaciones mayores (p < 0.0001). El grupo A tuvo mayor número de respuestas positivas (p < 0.0001).
La combinación de información verbal y escrita logra mejor nivel de conocimientos por el paciente.
The manner in which informed consent is obtained varies. The aim of this study is to evaluate the level of knowledge about colonoscopy and comparing 2 methods of obtaining informed consent.
A comparative, cross-sectional, observational study was conducted on patients that underwent colonoscopy in a public hospital (Group A) and in a private hospital (Group B). Group A received information verbally from a physician, as well as in the form of printed material, and Group B only received printed material. A telephone survey was carried out one or 2 weeks later.
The study included a total of 176 subjects (group A [n = 55] and group B [n = 121]). As regards education level, 69.88% (n = 123) of the patients had completed university education, 23.29% (n= 41) secondary level, 5.68% (n = 10) primary level, and the remaining subjects (n = 2) had not completed any level of education. All (100%) of the subjects knew the characteristics of the procedure, and 99.43% were aware of its benefits. A total of 97.7% received information about complications, 93.7% named some of them, and 25% (n = 44) remembered major complications. All the subjects received, read, and signed the informed consent statement before the study. There were no differences between the groups with respect to knowledge of the characteristics and benefits of the procedure, or the receipt and reading of the consent form. Group B responded better in relation to complications (P=.0027) and group A had a better recollection of the major complications (P<.0001). Group A had a higher number of affirmative answers (P<.0001).
The combination of verbal and written information provides the patient with a more comprehensive level of knowledge about the procedure.
Informed consent for GI endoscopy
2007, Gastrointestinal Endoscopy
Citation Excerpt :
Pre-endoscopic informed consent can be obtained at any time before sedation.26,27 It is also advisable that the endoscopist have a third party witness the informed consent interview.10,11 This witness to the informed consent process may prove invaluable in the event that any questions arise concerning the validity or extent of disclosure.
An integrative model of shared decision making in medical encounters
2006, Patient Education and Counseling
Given the fluidity with which the term shared decision making (SDM) is used in teaching, assessment and research, we conducted a focused and systematic review of articles that specifically address SDM to determine the range of conceptual definitions.
In April 2005, we ran a Pubmed (Medline) search to identify articles published through 31 December 2003 with the words shared decision making in the title or abstract. The search yielded 681 citations, 342 of which were about SDM in the context of physician–patient encounters and published in English. We read and reviewed the full text of all 342 articles, and got any non-redundant references to SDM, which yielded an additional 76 articles.
Of the 418 articles examined, 161 (38.5%) had a conceptual definition of SDM. We identified 31 separate concepts used to explicate SDM, but only “patient values/preferences” (67.1%) and “options” (50.9%) appeared in more than half the 161 definitions. Relatively few articles explicitly recognized and integrated previous work.
Our review reveals that there is no shared definition of SDM. We propose a definition that integrates the extant literature base and outlines essential elements that must be present for patients and providers to engage in the process of SDM.
The integrative definition of SDM is intended to provide a useful foundation for describing and operationalizing SDM in further research.
Patient recall and appropriate timing for obtaining informed consent for endoscopic procedures
1999, American Journal of Gastroenterology
OBJECTIVES:
Although informed consent is an issue in many medical malpractice claims, there is no standardized time or method to obtain informed consent for endoscopic procedures. The objectives of this study were to determine whether sedation for endoscopic procedures interfered with pre-endoscopic informed consent and to determine the appropriate time to obtain informed consent.
METHODS:
Patients undergoing a sedated esophagogastroduodenoscopy had informed consent obtained either 48–72 h before the procedure (group 1A, n = 50) or 10–60 min before the procedure (group 1B, n = 50). Patients undergoing an unsedated flexible sigmoidoscopy had informed consent obtained either 48–72 h before (group 2A, n = 47) or 10–60 min before the procedure (group 2B, n = 49). Methods of informed consent consisted of an oral and a written explanation about the procedure. Patients were sedated with midazolam and meperidine. A Trieger test evaluated recovery from sedation. Recall was assessed by asking six questions about the procedure before discharge and again 2–3 days later.
RESULTS:
Standard t tests and Mann-Whitney U nonparametric rank tests were used to compare the 1) 1-h recall scores, 2) 2–3-day recall scores, and 3) recall difference scores for groups 1A and 1B, 1A and 2A, 2A and 2B, and 1B and 2B. There were no differences in recall for the different groups.
CONCLUSIONS:
This study shows that sedation for endoscopic procedures does not interfere with pre-endoscopic informed consent. Informed consent for endoscopic procedures can be obtained at any time before sedation with similar recall.
Informed consent: a survey of physician outcomes and practices
1995, Gastrointestinal Endoscopy
We mailed a survey to the domestic membership of the American Society of Gastrointestinal Endoscopy in an attempt to investigate how endoscopists obtained informed consent and the effect of these practices on medical malpractice claims. One thousand two hundred thirty-two (23.8%) surveys were returned. We determined that although informed consent is obtained in 98.5% of endoscopic cases, 30% of physicians leave the task of obtaining such consent to hospital or office personnel. Although endoscopists tend to be complete in terms of describing the risks of procedures to patients, all risks are not revealed equally; some complications, for example, the risk for requiring a colostomy, are disclosed by relatively few physicians, perhaps revealing a higher comfort level with a particular procedure, such as colonoscopy. Like-wise, endoscopists generally explain the benefits of and alternatives to procedures, but they do not explain the more hazardous alternatives. Documentation of the informed consent process is an area in which physicians could be more thorough. Twenty-one percent of respondents had been sued, and in 42% of these instances, the informed consent process was an issue. Lawsuits in general (38%) changed the way respondents obtained consent, especially (64%) when this process had been an issue in the suit. No correlation was found between either the thoroughness of the informed consent process or the status of the person who obtained consent and the likelihood of being sued.
Informed consent for gastroenterologic procedures
1995, Gastrointestinal Endoscopy

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