Informed consent for GI 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*

Grade of Recommendation	Clarity of Benefit	Methodologic Strength/ Supporting Evidence	Implications
1A	Clear	Randomized trials without important limitations	Strong recommendation; can be applied to most clinical settings
1B	Clear	Randomized trials with important limitations (inconsistent results, nonfatal methodologic flaws)	Strong recommendation; likely to apply to most practice settings
1C+	Clear	Overwhelming evidence from observational studies	Strong recommendation; can apply to most practice settings in most situations
1C	Clear	Observational studies	Intermediate-strength recommendation; may change when stronger evidence is available
2A	Unclear	Randomized trials without important limitations	Intermediate-strength recommendation; best action may differ depending on circumstances or patients' or societal values
2B	Unclear	Randomized trials with important limitations (inconsistent results, nonfatal methodologic flaws)	Weak recommendation; alternative approaches may be better under some circumstances
2C	Unclear	Observational studies	Very weak recommendation; alternative approaches likely to be better under some circumstances
3	Unclear	Expert opinion only	Weak recommendation; likely to change as data become available

*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.

Brief Summary

GUIDELINE TITLE

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

BRIEF SUMMARY CONTENT

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

CLINICAL ALGORITHM(S)

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

DATE RELEASED

GUIDELINE DEVELOPER(S)

SOURCE(S) OF FUNDING

GUIDELINE COMMITTEE

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

GUIDELINE STATUS

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

NGC STATUS

COPYRIGHT STATEMENT

DISCLAIMER

NGC DISCLAIMER

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