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## Complete Summary

#### GUIDELINE TITLE

Informed consent for GI endoscopy.

#### BIBLIOGRAPHIC SOURCE(S)

Standards of Practice Committee, Zuckerman MJ, Shen B, Harrison ME 3rd,
Baron TH, Adler DG, Davila RE, Gan SI, Lichtenstein DR, Qureshi WA,
Rajan E, Fanelli RD, Van Guilder T. Informed consent for GI endoscopy.
Gastrointest Endosc 2007 Aug;66(2):213-8. \[38 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17643691)

#### GUIDELINE STATUS

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.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Any disease or condition requiring gastrointestinal endoscopy

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation\
Management

#### CLINICAL SPECIALTY

Family Practice\
Gastroenterology\
Internal Medicine

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

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

#### TARGET POPULATION

Patients undergoing endoscopy

#### INTERVENTIONS AND PRACTICES CONSIDERED

Obtaining and documenting informed consent from patients undergoing
gastrointestinal endoscopy

#### MAJOR OUTCOMES CONSIDERED

Not stated

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

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.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus (Committee)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

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

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Grades of Recommendation\***

  ----------------------------------------------------------------------------
  **Grade of             **Clarity   **Methodologic    **Implications**
  Recommendation**       of          Strength/\        
                         Benefit**   Supporting        
                                     Evidence**        
  ---------------------- ----------- ----------------- -----------------------
  1A                     Clear       Randomized trials Strong recommendation;
                                     without important can be applied to most
                                     limitations       clinical settings

  1B                     Clear       Randomized trials Strong recommendation;
                                     with important    likely to apply to most
                                     limitations       practice settings
                                     (inconsistent     
                                     results, nonfatal 
                                     methodologic      
                                     flaws)            

  1C+                    Clear       Overwhelming      Strong recommendation;
                                     evidence from     can apply to most
                                     observational     practice settings in
                                     studies           most situations

  1C                     Clear       Observational     Intermediate-strength
                                     studies           recommendation; may
                                                       change when stronger
                                                       evidence is available

  2A                     Unclear     Randomized trials Intermediate-strength
                                     without important recommendation; best
                                     limitations       action may differ
                                                       depending on
                                                       circumstances or
                                                       patients\' or societal
                                                       values

  2B                     Unclear     Randomized trials Weak recommendation;
                                     with important    alternative approaches
                                     limitations       may be better under
                                     (inconsistent     some circumstances
                                     results, nonfatal 
                                     methodologic      
                                     flaws)            

  2C                     Unclear     Observational     Very weak
                                     studies           recommendation;
                                                       alternative approaches
                                                       likely to be better
                                                       under some
                                                       circumstances

  3                      Unclear     Expert opinion    Weak recommendation;
                                     only              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.

#### COST ANALYSIS

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

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

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

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

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]{.underline}**:

**Grades of Recommendation\***

  ----------------------------------------------------------------------------
  **Grade of             **Clarity   **Methodologic    **Implications**
  Recommendation**       of          Strength/\        
                         Benefit**   Supporting        
                                     Evidence**        
  ---------------------- ----------- ----------------- -----------------------
  1A                     Clear       Randomized trials Strong recommendation;
                                     without important can be applied to most
                                     limitations       clinical settings

  1B                     Clear       Randomized trials Strong recommendation;
                                     with important    likely to apply to most
                                     limitations       practice settings
                                     (inconsistent     
                                     results, nonfatal 
                                     methodologic      
                                     flaws)            

  1C+                    Clear       Overwhelming      Strong recommendation;
                                     evidence from     can apply to most
                                     observational     practice settings in
                                     studies           most situations

  1C                     Clear       Observational     Intermediate-strength
                                     studies           recommendation; may
                                                       change when stronger
                                                       evidence is available

  2A                     Unclear     Randomized trials Intermediate-strength
                                     without important recommendation; best
                                     limitations       action may differ
                                                       depending on
                                                       circumstances or
                                                       patients\' or societal
                                                       values

  2B                     Unclear     Randomized trials Weak recommendation;
                                     with important    alternative approaches
                                     limitations       may be better under
                                     (inconsistent     some circumstances
                                     results, nonfatal 
                                     methodologic      
                                     flaws)            

  2C                     Unclear     Observational     Very weak
                                     studies           recommendation;
                                                       alternative approaches
                                                       likely to be better
                                                       under some
                                                       circumstances

  3                      Unclear     Expert opinion    Weak recommendation;
                                     only              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.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

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

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   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.

#### POTENTIAL HARMS

Not stated

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

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.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Standards of Practice Committee, Zuckerman MJ, Shen B, Harrison ME 3rd,
Baron TH, Adler DG, Davila RE, Gan SI, Lichtenstein DR, Qureshi WA,
Rajan E, Fanelli RD, Van Guilder T. Informed consent for GI endoscopy.
Gastrointest Endosc 2007 Aug;66(2):213-8. \[38 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17643691)

#### ADAPTATION

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

#### DATE RELEASED

1988 (revised 2007 Aug)

#### GUIDELINE DEVELOPER(S)

American Society for Gastrointestinal Endoscopy - Medical Specialty
Society

#### SOURCE(S) OF FUNDING

American Society for Gastrointestinal Endoscopy

#### GUIDELINE COMMITTEE

Standards of Practice Committee

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*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

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

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.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [American Society for
Gastrointestinal Endoscopy Web
site](http://www.asge.org/PublicationsProductsIndex.aspx?id=352).

Print copies: Available from the American Society for Gastrointestinal
Endoscopy, 1520 Kensington Road, Suite 202, Oak Brook, IL 60523

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

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

#### COPYRIGHT STATEMENT

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

### DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008