Guideline:
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
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 Category
Diagnosis
Evaluation
Management
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
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 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.
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.
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:
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.
Clinical Algorithm(s)
None provided
Type of Evidence supporting the Recommendations
The type of supporting evidence is identified for each recommendation (see "Major 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
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.
Description of Implementation Strategy
An implementation strategy was not provided.
IOM Care Need
Getting Better
IOM Domain
Effectiveness
Patient-centeredness
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
Adaptation
Not applicable: The guideline was not adapted from another source.
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.
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.
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This NGC summary is based on the original guideline which is subject to the guideline developer's copyright restrictions.
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