This is the current release of the guideline.

This guideline updates a previous version: American Society for Gastrointestinal Endoscopy. Guideline: informed consent for gastrointestinal endoscopy. Gastrointest Endosc 1988;34(Suppl):26S-7S.

Any disease or condition requiring gastrointestinal endoscopy

Diagnosis
Evaluation
Management

Family Practice
Gastroenterology
Internal Medicine

Physicians

To present to endoscopists a reasonable and effective method of obtaining adequate informed consent

Patients undergoing endoscopy

Obtaining and documenting informed consent from patients undergoing gastrointestinal endoscopy

Not stated

Searches of Electronic Databases

In preparing this guideline, MEDLINE and PubMed databases were used to search publications through February 2006 that related to the topic of "informed consent for gastrointestinal endoscopy" by using the keyword(s) "informed consent," "patient information," "risk," "gastrointestinal endoscopy," "endoscopy," "endoscopic procedures," and "procedures." The search was supplemented by accessing the "related articles" feature of PubMed, with articles identified on MEDLINE and PubMed as the references. Pertinent studies published in English were reviewed. Studies or reports that described fewer than 10 patients were excluded from the analysis if multiple series with more than 10 patients that addressed the same issue were available.

Not stated

Expert Consensus (Committee)

Not applicable

Systematic Review

Not stated

Expert Consensus

Guidelines for appropriate utilization of endoscopy are based on a critical review of the available data and expert consensus.

Grades of Recommendation*

*Adapted from Guyatt G, Sinclair J, Cook D, Jaeschke R, Schunemann H, Pauker S. Moving from evidence to action: grading recommendations—a qualitative approach. In: Guyatt G, Rennie D, eds. Users' guides to the medical literature. Chicago: AMA Press; 2002. p. 599-608.

A formal cost analysis was not performed and published cost analyses were not reviewed.

Internal Peer Review

This document was reviewed and approved by the Governing Board of the American Society for Gastrointestinal Endoscopy.

Recommendations were graded on the strength of the supporting evidence (Grades 1A-3). Definitions of the recommendation grades are presented at the end of the "Major Recommendations" field.

Summary

• The crux of informed consent is a combination of disclosure and voluntary decision making (grade 3).
• The essential elements of adequate disclosure are the nature of a proposed procedure or treatment, the reason the procedure is suggested, the material risks and benefits, and the reasonable alternatives to the proposed procedure (grade 3).
• The endoscopist should be certain to document that the patient's informed consent has been obtained before the performance of a procedure (grade 3).
• All informed refusals should be documented (grade 3).
• Recognized exceptions to the informed consent process include emergency, therapeutic privilege, waiver, and legal mandate (grade 3).

Definitions:

Grades of Recommendation*

*Adapted from Guyatt G, Sinclair J, Cook D, Jaeschke R, Schunemann H, Pauker S. Moving from evidence to action: grading recommendations—a qualitative approach. In: Guyatt G, Rennie D, eds. Users' guides to the medical literature. Chicago: AMA Press; 2002. p. 599-608.

None provided

The type of supporting evidence is identified for each recommendation (see "Major Recommendations").

• Appropriate obtaining and documentation of adequate informed consent in patients undergoing an endoscopic procedure.
• Informed consent can enhance patient understanding and protect physicians from liability in medical battery or other malpractice lawsuits.

Not stated

Further controlled clinical studies are needed to clarify aspects of this statement, and revision may be necessary as new data appear. Clinical consideration may justify a course of action at variance to these recommendations.

An implementation strategy was not provided.

Getting Better

Effectiveness
Patient-centeredness

Not applicable: The guideline was not adapted from another source.

1988 (revised 2007 Aug)

American Society for Gastrointestinal Endoscopy - Medical Specialty Society

American Society for Gastrointestinal Endoscopy

Standards of Practice Committee

Committee Members: Marc J. Zuckerman, MD; Bo Shen, MD; M. Edwyn Harrison III, MD; Todd H. Baron, MD, Chair; Douglas G. Adler, MD; Raquel E. Davila, MD; S. Ian Gan, MD; David R. Lichtenstein, MD; Waqar A. Qureshi, MD; Elizabeth Rajan, MD; Robert D. Fanelli, MD, SAGES Representative; Trina Van Guilder, RN, SGNA Representative

Not stated

This is the current release of the guideline.

This guideline updates a previous version: American Society for Gastrointestinal Endoscopy. Guideline: informed consent for gastrointestinal endoscopy. Gastrointest Endosc 1988;34(Suppl):26S-7S.

None available

None available

This NGC summary was completed by ECRI Institute on March 4, 2008.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.