PRACTICE RECOMMENDATIONS DEVELOPMENT MANUAL

PRACTICE

RECOMMENDATIONS

DEVELOPMENT MANUAL

A guidebook to assist individuals who write,evaluate and/or use AGA Institute Practice Recommendations.

Updated September 2007American Gastroenterological Association (AGA) Institute

Clinical Practice and Quality Management Committee

Copyright ©2007. All rights reserved.American Gastroenterological Association (AGA) Institute, Bethesda, MD

Contact Information for Questions

All questions regarding the technical content, scope, andobjectives of the guidelines manuscripts, general policiesgoverning AGA Institute guidelines, and Clinical Practiceand Quality Management Committee policies should bedirected to:

Sheila Agyeman, MHADirector of Evidence Based MedicineAGA Institute National Office4930 Del Ray Avenue, 6th floorBethesda, MD 20814Phone: 301-272-1189 (direct)Fax: [email protected]

She is also available to answer questions regardingmanuscript requirements and processing, procedures,teleconferences and meetings, and any other concerns.

Clinicians and others who have questions or comments aboutpublished guidelines and technical reviews should direct themin writing to:

Chair, Clinical Practice & Quality Management CommitteeAGA Institute National Office4930 Del Ray Avenue, 6th floorBethesda, MD 20814Phone: 301-654-2055

All guidelines and technical reviews can be found at

www.gastro.org/guidelines.

2 AGA Institute Practice Recommendations Development Manual0907

CONTENTSPart I: Introduction

Rationale for this manual ........................................................................................4

Part II: Basic Assumptions

Assumptions on which the AGA Institute PracticeRecommendations process and policies are based ................................................5

Part III: Process for Developing AGA Institute Practice Recommendations

Overview, flowchart.................................................................................................7

Types of Practice Recommendations ......................................................................9

Part IV: Instructions for Authors

Technical Review Panel: Writing the technical review ........................................11

Medical Position Panel: Writing the clinical practiceguidelines, consensus statements and measures ..............................................16

Administrative procedures ....................................................................................20

Manuscript technical specifications and procedures ............................................21

Part V: Appendix

Appendix A: Detailed process for developing AGA Practice Recommendations .....22

Appendix B: Process for reviewing existing guidelines.........................................26

Appendix C: Manuscript requirements for Gastroenterology .................................27

Appendix D: Guidelines for writing CME questions and learning objectives ....34

Appendix E: Copyright Assignment Form for Gastroenterology ..........................39

AGA Institute Practice Recommendations Development Manual0907

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4 AGA Institute Practice Rcommendations Development Manual0907

The American Gastroenterological Association (AGA) Institute is dedicated toadvancing the science and practice of gastroenterology. Practice recommendations are animportant tool for educating physicians and guiding their patient-care decisions. Payersand purchasers have used practice recommendations to develop coverage and paymentpolicies for medical care and to establish benchmarks for “quality” or “appropriate” care(including pay-for-performance, or P4P, standards).

The AGA Institute is committed to the ongoing development of practicerecommendations. Formal recommendations are developed in a defined area ofgastroenterology practice, based both on the scientific literature and the collectiveopinions of expert physicians. In essence, by developing a practice recommendation, theAGA Institute is doing for physicians what they would do on their own if they had thetime, expertise and support to compile, compare and evaluate numerous clinical researchstudies, obtain the opinions of multiple expert consultants, and synthesize theinformation into a set of policies and procedures.

With practice recommendations playing a central role in today’s value-drivenmedical marketplace, it is imperative that gastroenterology establish its own position andrecommendations, rather than let others fill this need.

The first step in the AGA Institute’s practice recommendations development processis the compilation of a technical review, which is a comprehensive background paperbased on medical and scientific evidence. Once a technical review is written, threepossible documents will emerge, based on the strength of the evidence:

1. CONSENSUS STATEMENT – a statement on an area of controversy,identification of reasonable practice or identification of future areas of studywhere less evidence is available.

2. CLINICAL PRACTICE GUIDELINE – a set of recommendations where strongerevidence is available.

3. MEASURES – a set of performance measures for use in pay for performance orother quality initiatives.

This manual is intended to guide authors of practice recommendations and to serveas a reference for those who review and evaluate practice recommendations. Authors’conformance with AGA Institute’s practice recommendation development process shouldlead to the creation of recommendations that are useful to physicians and beneficial forpatients.

PART I: INTRODUCTION

The AGA Institute’s practice recommendations development process rests on thefollowing assumptions:

1. Purpose.

Physician education is one of the main purposes of practice recommendations.Though often used for other purposes, such as reimbursement decisions orhospital quality assessment criteria, practice recommendations are developed toeducate physicians and guide their patient-care decisions. Practicerecommendations should not replace professional clinical judgment based onexperience and patient-specific circumstances. The ultimate goal is to improvepatient outcomes.

2. AGA Institute’s Role.

AGA Institute is a major center for the development of gastroenterology practicerecommendations. It is critical that the professional societies that represent thefield of gastroenterology take the lead in developing and issuing such practicerecommendations consistent with available science and expert consensus opinion.Unless explicitly noted to the contrary, AGA Institute practice recommendationsrepresent the official opinion of the AGA Institute, and reflect the opinions ofindividuals involved in developing the position paper.

3. Quality and Cost Implications for Health Care.

Research and literature highlight the impact of variation in care on health carequality and outcomes. Practice recommendations and their use in practicesupport consistent care and can address gaps and variation in care. As someresearch suggests that better quality care is less costly than poor quality care,practice recommendations can potentially lower health care expenditures byeliminating unnecessary or ineffective practices and procedures. However, it isimportant to note that the primary focus of AGA Institute practicerecommendations is neither cost containment nor reduction of resource use.

Third-party payers often link official practice recommendations toreimbursement and payment policies. In some cases, these policies may be themajor reason(s) for developing practice recommendations, i.e., the need to have

PART II: BASIC ASSUMPTIONS


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“something official on paper.” However, such financial considerations or healthplan benefits alone, should not be used as the rationale for any clinical practicerecommendation.

4. Legal Implications.

Practice recommendations have been, and will continue to be, used to defineappropriate or adequate medical care in professional malpractice actions. Allclinicians will be held accountable to any relevant practice standards, which canalso provide legal protection to defendants. Thus, it is important to wordrecommendations carefully, and clearly define situations in whichrecommendations are applicable.

5. Due Process.

Given the potential implications of these recommendations to patients andphysicians, it is imperative that they be developed via a deliberative, open and dueprocess. The system adopted by AGA Institute meets these characteristics andenables us to respond to questions of the veracity or appropriateness of any ofour recommendations.

6. Scientific Data vs. Opinion.

To the extent possible, AGA Institute practice recommendations will be based onvalid, scientific data. However, there are situations when such data areinconclusive or absent. Therefore, some recommendations will be based partially,or even wholly, on expressions of expert opinion. While offering such opinions ispreferable to remaining silent on an issue, it is AGA Institute policy to clearlyidentify the degree to which a practice recommendation document reflects hardfacts versus consensus opinion. If practice recommendations rely on consensusopinion, they are generally not suitable for adoption as a quality metric for P4Pstandards.

7. Dissemination of practice recommendations.

Dissemination of practice recommendations to medical professionals, and to thepublic, is important. Therefore, all practice recommendation documents will bewidely disseminated in AGA Institute publications and other media. Consideredpublic documents, they will be made available to all interested parties uponrequest.


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PART III: THE PROCESS FOR DEVELOPINGAGA INSTITUTE PRACTICE RECOMMENDATIONS

Step 1Clinical Practice & Quality

Management Committee (CPQC),AGA Institute Council, Governing Boardand/or AGA member (s) identify topic(s)to be developed within the coming year.

Step 3Technical Review Panel (TRP) is

formed consisting of the authors, memberof CPQC, and member of appropriateCouncil section. TRP drafts technicalreview.

Step 2The CPQC approves final topics,

determines scope of topic(s) and objectivesfor technical review. AGA InstituteCouncil identifies and secures authors andexternal reviewers via the appropriateCouncil section.

Step 4TRP determines what type of practice

recommendation to produce, based onquality of evidence in technical review:consensus statement, guideline ormeasures (for use in P4P or otherquality-improvement efforts).

Step 5A Medical Position Panel (MPP)

consisting of 3-4 members of TRP,community-based GI, primary carephysician, payer, surgeon (if applicable),patient/patient advocate andgastroenterologist, convene to writethe official guideline.

Step 7“Final” draft of guideline sent to

CPQC. CPQC members on TRP presentguideline to full committee for review.Necessary final edits made prior tosubmission to AGA Institute GoverningBoard.

Step 6Final draft of guideline sent to external

reviewers for review and comment. MPPresponds to external review comments.

Step 8Governing Board reviews and approves

guideline and corresponding technicalreview. Publication in Gastroenterology.


Technical ReviewsA technical review is a background paper from which the consensus statement,clinical practice guideline and measures are derived. Its purpose is to provide theuser with the evidence utilized to formulate a particular recommendation. Thestrength and character of that evidence is also ranked based on the U.S.Preventative Services Task Force Ratings.

The practice recommendations will be published along with its correspondingtechnical review. The primary reason for producing both documents is that theyprovide flexibility in disseminating the recommendations they each contain.Authors of technical reviews are expected to produce a paper of publishablequality. Technical reviews will be published in Gastroenterology.

Clinical Practice GuidelinesThere are numerous accepted definitions of evidence-based clinical practiceguidelines and processes for their development. Methods used to produceclinical practice guidelines range from the very rigorous lengthy and expensiveprocess described in the Institute of Medicine’s (IOM) Clinical PracticeGuidelines: Directions for a New Program to the simple, but scientifically soft,issuance of guidelines consisting of the unsupported opinions of a few experts.The process described herein represents a workable balance between these two

The AGA Institute issues threetypes of practice recommendationdocuments: consensus statements,clinical practice guidelines andperformance measures or qualityindicators for quality improvementand/or P4P initiatives. The basis ofthese three documents is a technicalreview. A technical review is acomprehensive background paperbased on evidence-based literature.

TYPES OF AGA INSTITUTE

PRACTICE RECOMMENDATION DOCUMENTS


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Technical Review

ConsensusStatements

ClinicalPractice

Guidelines

Measures


extremes. A clinical practice guideline is a concise expression of the AGAInstitute’s official opinions and clinical practice recommendations on a givensubject. The guideline is based on the relevant technical review.

Consensus StatementsConsensus statements represent the opinion of an expert panel convened by theAGA Institute to address a set of specific questions related to a defined medicalpractice issue. Typically, outside experts are invited to present their answers tothese questions based on their interpretation of the relevant evidence which thetechnical review provides. The expert panel then convenes to develop its answersto the questions based on the presentations it received. The panel produces areport suitable for publication in an AGA Institute journal. This reportrepresents the opinions of the panel, not the AGA Institute.

MeasuresQuality Indicators a set of metrics that are less evidence based and often processoriented.

Performance measures are metrics that: (1) measure the degree ofaccomplishment of a health objective, (2) are generally developed from evidence-based guidelines, and (3) measure health outcomes.

Composite measures are a set of measures used to better understandinformation from numerous individual measures. When strong evidence andguidelines exist, composite measures reflect the quality/outcomes of the care witha set of measures which together reflect care of chronic/complex patientconditions.


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PART IV: INSTRUCTIONS FOR AUTHORS

Technical Review Panel: Writing the technical review

Title FormatThe papers should be titled: “AGA Institute Technical Review on [topic].”

Structure and OrganizationThe form of a technical review may vary somewhat depending on the subject matter. It

should, however, at least contain the following sections:

1. Introduction that includes:— Subject of the technical review. This could be specific procedures or treatments

or management of a defined patient problem.— Importance of the issue (e.g., patient outcomes, cost & implications).— Objectives and contents of technical review.— List of key questions technical review will address.

Particular emphasis should be given to issues such as:1) when a patient will or will not need intense diagnostic or therapeutic

measures;2) the hierarchy and sequence of recommended diagnostic or therapeutic

interventions.

2. Literature review and analysis that includes:— The basis for the paper’s conclusions and recommendations. Should contain the

authors’ compilation and assessment of the relevant experimental, clinical andepidemiological data (not necessarily all three) on the topic.

— Relevant quality, cost-effectiveness and cost-benefit data if available.The following information should be included in this section:(Note: AGA Institute staff will perform literature searches. A compilation and comparison ofthis information and the study quality descriptions will be provided to authors in a tabulardisplay similar to what is shown in Figure 1.)

— Criteria used to include and/or exclude data from consideration (e.g.,studies published only as abstracts were excluded; only clinical studies

published after 1997 were included).— Description of the electronic and manual search process, including

search terms used.— Short descriptions of the studies cited. Description should include

such factors as study design, clinical endpoints, randomization,number of subjects, controls employed and blinding.

— Rank the strength of the level of evidence for all references using theU.S. Preventive Services Task Force (USPSTF) Ratings (see Figure 2).

— Quality of cited studies. Indicate their respective strengths (Well-controlled? Prospective? Randomized double-blinded trial? Goodstatistical power?) and limitations (Short study period? Small patientpopulation? Questionable therapeutic endpoints?).

3. Conclusions and clinical practice recommendations based on the foregoinganalysis. Clinical recommendations should:

— Define the patient populations to which the recommendations do anddo not apply. For example, some recommendations may not beindicated for particular types of patients by virtue of their age or sex.

— Indicate type of health care provider to which the recommendationsapply. Some recommendations may be applicable to gastroenterologyspecialists but not to primary care physicians.

— Type of practice recommendation (guideline, consensus statement,measures) that should be produced based on the quality of evidence.

— Outcomes expected from the recommendations.— Whether or not specific recommendations lend themselves to

performance measure development. If they do, authors shoulddescribe the performance measures and identify a way to measuretheir impact or outcomes. If applicable, include suggestions on whatdata or research methods could be used (e.g., chart review,administrative data, surveys).

Recommendations should be worded so the reader is clear that they representpublished literature, the authors’ opinions or both. The latter often will be the casewhere the supporting data are suggestive, not conclusive.

4. The authors’ suggestions for future research indicating:— Areas requiring further research studies due to insufficient data, no data, poor

quality data or conflicting data. This can be included as a separate section of thedocument or integrated into the review and analysis section.

5. The references cited in the body of the paper. These should be in the style usedby Gastroenterology (see Appendix C). Abstracts from meetings (published orunpublished) should be clearly identified as such and should be used only when nocomparable studies exist. Primary reference sources are preferred over textbooks orother secondary reference sources. Letters and case reports should be usedcautiously. Unpublished studies are not acceptable. References should be cited innumerical order in the text by number, not author’s name or publication date.


Fig.

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A

B

C

D

I

The USPSTF strongly recommends that clinicians provide [the service] to eligible patients. TheUSPSTF found good evidence that [the service] improves important health outcomes andconcludes that benefits substantially outweigh harms.

The USPSTF recommends that clinicians provide [this service] to eligible patients. The USPSTFfound at least fair evidence that [the service] improves important health outcomes and concludesthat benefits outweigh harms.

The USPSTF makes no recommendation for or against routine provision of [the service]. The USPSTFfound at least fair evidence that [the service] can improve health outcomes but concludes that thebalance of benefits and harms is too close to justify a general recommendation.

The USPSTF recommends against routinely providing [the service] to asymptomatic patients. TheUSPSTF found at least fair evidence that [the service] is ineffective or that harms outweighbenefits.

The USPSTF concludes that the evidence is insufficient to recommend for or against routinelyproviding [the service]. Evidence that the [service] is effective is lacking, of poor quality, orconflicting and the balance of benefits and harms cannot be determined.

Quality of EvidenceThe U.S. Preventive Services Task Force (USPSTF) grades its recommendations according to one of fiveclassifications (A, B, C, D, I) reflecting the strength of evidence and magnitude of net benefit (benefits minus harms).

Good

Fair

Poor

Evidence includes consistent results from well-designed, well-conducted studies in representativepopulations that directly assess effects on health outcomes.

Evidence is sufficient to determine effects on health outcomes, but the strength of the evidenceis limited by the number, quality, or consistency of the individual studies, generalizability to routinepractice, or indirect nature of the evidence on health outcomes.

Evidence is insufficient to assess the effects on health outcomes because of limited number orpower of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lackof information on important health outcomes.

Internet Citation: U.S. Preventive Services Task Force Ratings: Strength of Recommendations and Quality ofEvidence. Guide to Clinical Preventive Services, Third Edition: Periodic Updates, 2000-2003. Agency forHealthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/3rduspstf/ratings.htm

Fig. 2 U.S. Preventive Services Task Force (USPSTF) Ratings

Strength of RecommendationsThe U.S. Preventive Services Task Force (USPSTF) grades its recommendations according to one of fiveclassifications (A, B, C, D, I) reflecting the strength of evidence and magnitude of net benefit (benefits minus harms).


Though there is no set number of reference citations for a technical review,generally, the list should not exceed 125. The selection and number of references isleft to the judgment of the authors. Most technical reviews will contain 75-100references.

6. Continuing Medical Education (CME) questions and learning objectives.Since 2006, the AGA Institute has offered CME credits related to each technicalreview published. The Technical Review Panel prepares 7 questions and answers foronline CME credits. CME questions and answers are reviewed along with thetechnical review. The TRP should also prepare 3 learning objectives for the paper.See appendix D for guidance on developing CME questions and learning objectives.

LengthThe length of a technical review will vary according to the subject matter, however the

typical length is 10-30 double-spaced typewritten pages.

Authorship & PublicationTechnical reviews will be published in the print and/or online versions of the AGA

Institute journals as AGA Institute documents authored by Technical Review Panelmembers listed in alphabetical order. Technical reviews will not be subject to thejournals’ normal manuscript review process. However, all manuscripts will be copyedited for grammar, conciseness, and clarity, and are subject to the journal’s style andother production requirements.

External ReviewAll technical reviews are sent to external reviewers. The Technical Review Panel will be

expected to consider their critiques carefully. AGA Institute staff will distributedocuments to reviewers and return comments to the Technical Review Panel. Leadauthor(s) are welcome to solicit the advice and critiques of colleagues at any point in thepaper’s development. All copies of draft manuscripts should be prominently marked“DRAFT-- Not for Distribution.”

ApprovalFinal Approval of technical review rests with the CPQC and Governing Board.


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Medical Position Panel: Writing the officialAGA Institute Clinical Practice Guideline

Title FormatClinical practice guidelines should be titled as “AGA Institute Clinical Practice

Guideline: [on] [for] XYZ.”

Structure and OrganizationGuidelines will have two sections: a short introduction and the main body of the paper,

which presents the AGA Institute’s recommendations:1. The introduction will contain the following elements:

— A clear definition of the issue being addressed.— Discussion of the importance of subject, including clinical and/or policy

considerations.— Description of the types of patients or clinical situations to which the guidelines

apply or do not apply.— A statement describing the provider audience to which the recommendations apply.

2. Recommendations should be formatted as follows:— Bulleted or numbered statements or paragraphs.— Each recommendation should be followed by a summary paragraph describing

the quality of the evidence and the global U.S. Preventive Services Task Force(USPSTF) (see figure 2) score for each recommendation. Recommendationsmust be consistent with those of the technical review.

— Recommendations relating to therapies, treatments, or procedures should beexplicitly labeled as standards, guidelines or clinical alternatives. They arecharacterized as follows in AGA Institute documents:

a. Standard: A recommendation considered to be a standard of practiceapplies virtually without exception to all patients or situations definedin the guideline, is strongly supported by the clinical research literature(epidemiological and experimental studies generally would beconsidered to be weaker support), and is based almost totally on hardfacts. The words “must” and “shall” will be found in standards.

b.Clinical practice guidelines: A recommendation, or set ofrecommendations, intended to assist the physician in making patient caredecisions. In most cases the recommendation should be followed, but thedecision to do so is at the option of the physician, based on the circumstancesof the individual case at hand. Support in the research literature forguidelines ranges from suggestive to strong; hence, the guidelines will bebased, to some degree, on expert opinion. The words “should,” “usually,”and “generally” will be used in guidelines as opposed to “must” or “shall.”

c.Clinical alternative: Frequently, two or more treatments/therapeuticapproaches, often including a “no-treatment” option, may be equallyacceptable. This may be because the research literature does not stronglysupport one over the other, because the data upon which a choice could bebased are nonexistent, or because the data supporting a particular option are



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judged to be weak. In this case, recommendations should be presented as a setof alternatives, the choice of which is left solely to the physician. Clinicalalternatives should be presented in a neutral fashion: e.g., “Data on thecomparative efficacy of A vs. B have not been reported; hence, arecommendation cannot be made at this time.” If a preference is stated, itshould be made clear that it represents opinion or common practice only. Forexample: “It is common practice to first try XYZ; however, data to supportthis approach over ABC or DEF are lacking,” or “The choice of A, B, or C iscontroversial. It is our belief that A is the most promising; however, furtherresearch is needed to substantiate this opinion.” Words such as “could”“might” and “may” will be found in statements of clinical alternatives.

3. Quality Indicator or Performance Measure:Each guideline will include suggested quality indicators or measures as tools tosupport practices in compliance with the guideline. One to five quality indicators/measures should be provided.

LengthA guideline should not exceed four double-spaced, typewritten pages.

Authorship & PublicationAll members of the Medical Position Panel are listed, but there are no official authors

of the statement as it serves as the official position of the AGA Institute. The CPQC maychange or rewrite the guideline as they deem appropriate. This emphasizes the fact thatthe guideline is the opinion of the AGA Institute as a whole, not of any individual orgroup of individuals. All AGA Institute guidelines will be edited for grammar and clarityand published in the AGA Institute journal Gastroenterology.

ReferencesAuthors must cite the companion technical review as the source of the data and for further

details to what the guidelines contain. Generally, there should be no need to refer to primaryliterature references as these should have been included in the technical review.

External ReviewAll guidelines are sent to external reviewers. The Medical Position Panel will be expected to

consider their critiques carefully. AGA Institute staff will distribute documents to reviewersand return comments to the Medical Position Panel. Lead author(s) are welcome to solicit theadvice and critiques of colleagues at any point in the paper’s development. All copies of draftmanuscripts should be prominently marked “DRAFT-- Not for Distribution.”

ApprovalFinal Approval of guidelines rests with the CPQC and Governing Board.

Writing the AGA Institute ConsensusStatement

The CPQC will select a panel of experts, which may include members of the TechnicalReview Panel, to write the consensus statement. This statement will address a definedmedical practice issue for which evidence is weak by addressing a set of specific clinicalquestions. Outside experts on the topic will be invited to present their answers to thepanel. The expert panel will then convene to develop the official consensus statement. Aprofessional medical writer, if needed, may be retained to assist the panel in writing itsreport and expedite its development

Title FormatConsensus statement should be titled as: “AGA Institute Consensus Statement [on]

[for] XYZ

Review & ApprovalFinal approval of the consensus statement rests with the CPQC.



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Developing AGA Institute Quality/Performance Measures

The development of measures through the AGA Institute practice recommendationsprocess is one mechanism by which the need for quality measures development isidentified and executed.

Title FormatQuality/Performance Measure should be titled as: “AGA Institute Quality/

Performance Measures [on] [for] XYZ”

Structure and OrganizationMeasures documents will have three sections: a short introduction, the measures and

proposed coding/data collection.— Introduction includes background and evidence upon which measures based.— Measures include defined metrics (numerators and denominators) with inclusion

and exclusion criteria.— Proposed coding includes data elements necessary for establishing the numerator

and denominator.

External ReviewThe final draft of measures should be released for a 30-day public comment period.

This will meet the requirements of measure endorsement entities should the AGAInstitute decide to seek endorsement of a measure or set of measures.

Administrative Procedures

A letter confirming deadlines and other administrative requirements will be sent to theauthor(s) by staff at the AGA Institute National Office. For record keeping purposes, theauthor(s) will sign and return their agreements upon receipt of the materials. Paperdeadlines are closely monitored and authors must meet them in order to adhere to strictpublication deadlines.

ExpensesAGA Institute will cover the following expenses associated with producing a technical

review and the corresponding guideline:— Face-to-face meetings.— Teleconferencing and long-distance phone charges.

Payment of indirect (overhead) expenses is not permitted. Expenditures for items otherthan those listed above must be approved in advance by the AGA Institute NationalOffice.



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Manuscript Technical Specifications andProcedures

Compliance with the following manuscript specifications will facilitate processing andpublication of technical review and clinical practice guideline manuscripts.

1. Authors of practice recommendations should provide the AGA Institute NationalOffice with both a double-spaced hard copy and an electronic version in MicrosoftWord (Windows 97-2003 version).

2. Each line on each page of the manuscript should be consecutively numbered alongthe margin.

3. A header should be placed in the upper right corner of the document and include anabbreviated title of the manuscript, the date and page number.

4. When practice recommendations receive the requisite final approval(s), it will besubmitted to the editor of Gastroenterology for publication. Therefore, thepublication requirements of the journal regarding reference style, margins, etc.should be followed. A copy of the journal’s manuscript requirements is included inthe appendix of this manual. The AGA Institute National Office will coordinate thisprocess.

APPENDIX - A: DETAILED STEPS OF

PRACTICE RECOMMENDATIONS

DEVELOPMENT PROCESSThe process by which AGA Institute clinical practice guidelines are developed is

shown below. The time interval from the decision to prepare a technical review toapproval by the Board of Governors of the final corresponding clinical practice guidelinewill be approximately 12 months.

Step 1.The Clinical Practice & Quality Management Committee (CPQC), AGA

Institute Council, Governing Board and/or AGA Institute member identifiestopic(s) to be developed within the coming year.

A formal “call for topics” is made to AGA members with list of criteria, in July of eachyear. This call for topics is published in AGA eDigest, and/or other AGA Instituteelectronic or print publications. The CPQC prioritizes and ranks the list of topics andfinalizes the list based on the following equally weighted criteria: strength of evidence;importance in clinical practice, importance in payment and to payers; importance in P4P(potential for development of performance measures); variation in care; and prevalenceand cost of disease.

Step 2.The CPQC approves final topics, determines scope of topic(s) and objectives for

a technical review. AGA Institute Council Chair via the appropriate Councilsection identifies and secures authors and external reviewers.

The CPQC has the final approval of topic(s), determines the scope of topic(s) andobjectives for the technical review. When a new practice recommendation is to bedeveloped, the CPQC will create a written description of its assessment objectives andgeneral content to guide prospective authors.

Step 3.Technical Review Panel (TRP) is formed consisting of the authors, member of

CPQC, and member of appropriate Council section. TRP drafts technical review.

After authors on the TRP are secured, they will work with the Director of Evidence BasedMedicine to collate, synthesize, interpret and evaluate evidence to support writing oftechnical review (and quality indicators and/or measures). The TRP will then draft thetechnical review. Since 2006, the AGA has offered CME credits related to each technicalreview published. The TRP prepares 7 questions and answers for online CME credits.Those CME questions and answers are reviewed along with the technical review.



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Step 4.TRP determines what type of practice recommendation to produce, based on

the quality of evidence in technical review: consensus statement, guideline, ormeasure(s) (for use in pay for performance or other quality improvement efforts).

The TRP determines what type of statement to produce, based on the quality of theevidence. A consensus statement is based on an area of controversy, identification of reasonablepractice or identification of future areas of study, where less evidence available. A guideline is astatement written when stronger evidence available. The statement written may also includemeasures for use in P4P or other quality-improvement efforts.

Step 5.A Medical Position Panel (MPP) convenes to write the official practice

recommendation.

The MPP should consist of no more than 8-9 members, to include the 3-4 members of theTRP, a community-based GI, primary care physician, a payer, a surgeon (if applicable), apatient/patient advocate and a gastroenterologist with expertise in health services research.The MPP holds one face-to-face meeting, and teleconferences, as needed.

The TRP members present the literature to the larger MPP Panel. The MPP willcategorize the strength of recommendations and quality of evidence using the U.S.Preventive Services Task Force (USPSTF) Ratings to support both the AGA Instituteguideline and quality efforts. The MPP will consider the impact of the statement (orguideline) on quality of care in the practice of gastroenterology.

The MPP will propose quality indicators or performance measures for 1) guidelinecompliance if the statement is a guideline, or 2) quality improvement for other types ofstatements. The format of the statement should include each recommendation followed by asummary paragraph describing the quality of the evidence and the global USPSTF score foreach recommendation.

When the statement is published, each recommendation should be explicitly rated as towhether or not it would be suitable for the development of P4P measures.

Step 6.Final draft of practice recommendation and technical review sent to external

reviewers for review and comment. MPP responds to external review comments.

All Clinical Practice Guidelines and Technical Reviews are submitted in draft form toexpert reviewers. Reviewers are chosen based on their recognized expertise andknowledge of the subject of the position paper or of particular aspects of it. Collectively,reviewers will be representative of the clinical practice and clinical research communitiesand of gastroenterology and primary care medicine.

Reviewers will be asked to consider how well the draft or sections thereof answersquestions, objectives and concerns brought up in the letter of invitation. In general, theiranswers to the following will be solicited:

1. Have the authors clearly stated the objectives of the paper?

2. Have the topic and type of patient or clinical situations to which itapplies been clearly defined?

3. Have the authors included all relevant references in their review?Have they included any references that should be removed?

4. Have the criteria for selecting/rejecting references been given?

5. Have the cited studies and their respective results/conclusions beenaccurately represented?

6. Is the paper balanced and objective? Are there any apparent biasesregarding selection of studies discussed? Have the relevant risks(including cost) and benefits of any recommended procedure/therapybeen presented adequately?

7. Have the authors identified the extent to which their variousrecommendations are based on scientific data or expert opinion?

8. If analytic measures such as meta-analysis were used, were they usedcorrectly?

9. Have the authors identified the outcomes that can be expected fromfollowing the guidelines?

10.Are the indicators for various diagnostic and therapeutic interventionsclearly defined?

11.Are specific recommendations given when an intervention issuperfluous, when optional and when mandatory?

12.Is the sequence in which various measures are to be taken sound,practical and economical?

13.Is adequate space given to alternative approaches?

14.Did the authors identify issues in need of further study or consensusdevelopment?

15.Have the authors stated whether or not a recommendation will besuitable for development of quality indicators or performancemeasures?

Step 7.“Final” draft of practice recommendation and technical review is sent to CPQC.

The CPQC members on TRP present papers to full committee for review.Necessary final edits are made prior to submission to the Governing Board.

The CPQC members serving on the TRP will present the document to the fullCommittee either via e-mail, teleconference or during a Committee meeting for theCPQC’s thumbs up/down review. Prior to submission to the Governing Board, themanuscript will be sent to a copy editor to be made as concise as possible without losingmeaning.



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Step 8.Governing Board reviews and approves practice recommendation (and

corresponding technical review) for publication in GGaassttrrooeenntteerroollooggyy.

The approved versions of the guideline and technical review will be transmitted to theeditors of AGA’s journal for publication. The guideline and the technical review will bepublished in Gastroenterology.

The AGA Institute conducts a web-based discussion board regarding newly publishedguidelines and technical reviews during the month they’re published in Gastroenterology.The discussion board helps to alert AGA members about the new paper and also providereaders a chance to ask the authors direct questions about the paper through a securechannel.

Staff will monitor the discussion board. However, the lead author (or designatedcoauthor) will be expected to log onto the message board a few times a week for aboutone month to check for and answer any questions about the guideline and technicalreview. Login information will be provided to authors.

In cooperation with our journals’publisher Elsevier, AGA Institute will make guidelinesand technical reviews which have been approved by our Governing Board available tomembers ahead of publication. Once a guideline has been approved by the GoverningBoard it will be placed in a section of our journals’ websites (www.gastrojournal.org;www.cghjournal.org) known as Articles in Press. It will be a PDF file of the uneditedmanuscript that has been accepted for publication. The manuscript will undergocopyediting, typesetting, and review of the resulting proof before it is published in itsfinal form. Once this process is complete and the paper has been reviewed by the author,it will then replace the unedited version under Articles in Press. This final version willthen be indexed in Pubmed ahead of print. To access content housed under the Articlesin Press section, a username and password is necessary. Please note that during theproduction process errors may be discovered which could affect the content, and all legaldisclaimers that apply to the journal pertain.

Reprints of AGA Clinical Practice Guidelines and Technical Reviews will be producedand made available at the AGA National Office as well as on the AGA Web site atwww.gastro.org.

APPENDIX - B: PROCESS FOR

REVIEW OF EXISTING GUIDELINES

Step 1.Annually, the Clinical Practice and Quality Performance Committee (CPQC) will

screen all current AGA Institute guidelines (formerly medical position statements) andwill rank the topics to determine if they are outdated. If they are determined to beoutdated, then committee members will need to determine if they still impact the scopeof the GI practice. If not, they should be withdrawn or updated.

Step 2. The Committee determines topics requiring revision based on (1) importance to

clinical practice, (2) change in variation of care, and (3) prevalence and cost of disease.Staff will tally the information and present it to the committee during their Septembermeeting to discuss and finalize the revision schedule.

Step 3.The Committee will determine the appropriate number of topics to be revised under

the new practice recommendation development process. The number will be determinedby the rankings of the topics based upon the criteria on the ranking form. All topics willbe reviewed annually.

Each year the CPQC will be presented with a revised list of topics to once again rateand rank and discuss during their September committee meeting.



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APPENDIX - C: GASTROENTEROLOGY

MANUSCRIPT INSTRUCTIONS

GGaassttrrooeenntteerroollooggyy publishes clinical and basic studies of all aspects of the digestivesystem, including the liver and pancreas, as well as nutrition. The types of articlesGGaassttrrooeenntteerroollooggyy publishes include original papers, review articles, case reports, andspecial category manuscripts. Manuscripts must be prepared in accordance with the“Uniform Requirements for Manuscripts Submitted to Biomedical Journals” developedby the International Committee of Medical Journal Editors (N Engl J Med1991;324:424-428).

GGaassttrrooeenntteerroollooggyy has a total circulation of approximately 16,000 — about 11,500 in theUnited States and 4500 in other countries. Forty-five percent of subscribers are AGAmembers. In the United States, about 75% of subscribers are physicians, and about 25%of subscriptions go to residents, medical schools, and libraries. More than half of thepapers published originate overseas.

GGaassttrrooeenntteerroollooggyy is abstracted and indexed in Biological Abstracts, CABS, ChemicalAbstracts, Current Contents, Excerpta Media, Index Medicus, Nutrition Abstracts, andScience Citation Index.

Ethical and Legal Considerations — EthicsGGaassttrrooeenntteerroollooggyy strongly discourages the submission of more than one article dealing

with related aspects of the same study. In almost all cases, a single study is best reportedin a single paper.

The Journal editors consider research/publication misconduct to be a serious breach ofethics and will take action as necessary to address such misconduct, which includessubmission or publication of information that:

1. Is intentionally erroneous,2. Has been published elsewhere by a different author without

acknowledgment (plagiarism),3. Has been published elsewhere by the same author without

acknowledgment (duplicate publication), or4. Is subsequently published elsewhere by the same author without

acknowledgment, attribution, or permission from the AGA Institute, asholder of the copyright, to reprint or adapt the material.

Each author who submits a manuscript must complete the GGaassttrrooeenntteerroollooggyy CopyrightAssignment, Authorship Responsibility, NIH Funding, Financial Disclosure, andInstitutional Review Board/Animal Care Committee Approval Form, therebyaffirming that:

1. None of the material in the manuscript is included in anothermanuscript, has been published previously, or is currently underconsideration for publication elsewhere. This includes symposiaproceedings, transactions, books, articles published by invitation, andpreliminary publications of any kind except an abstract of less than 400words. If there is any potential overlap with a manuscript previouslypublished by the authors, the related manuscripts must be included for

editorial evaluation.2. Only people who contributed to the intellectual content, the analysis of

data, and the writing of the manuscript are listed as authors and that allauthors take public responsibility for the research results beingreported.

3. Ethical guidelines were followed by the investigator in studies onhumans or animals and described in the paper. The approval of theinstitutional review board of animal care committee must be cited inthe Methods section of the text.

Breaches in these standards may result in proscribed submission for all authors of theconcerned manuscript and, when appropriate, notification of the authors’ institutions.All authors are fully responsible for the content of the manuscript.

The publication of abstracts is not considered duplicate publication but should bedisclosed in the cover letter accompanying the manuscript submission.

Disclosure PolicyI. Authors (Original Articles and Review Articles)The following information must be included on the title page of submitted

manuscripts:— A list for all authors that discloses any financial arrangement (e.g.,

consultancies, stock ownership, equity interests, patent-licensingarrangements, research support, major honoraria, etc.) they may havewith a company whose product figures prominently in the submittedmanuscript or with a company making a competing product.Interactions that occur from the start of the research activity in thespecific program until the time when the paper is anticipated to bepublished or one year from submission date, whichever is longer, arepertinent. In the absence of any conflict of interest, authors must makethe statement that there is no conflict to disclose.

— A statement of all funding sources supporting the work and allinstitutional or corporate affiliations.

— Individuals who provided writing assistance for the manuscript and thefunding source for this assistance must be disclosed.

— Investigators must disclose potential conflicts to study participants andmust state whether they have done so.

All phase II or III trials pertaining to a commercial product (pharmaceutical or device)require:

— A statement that the statistical analysis of the entire data setspertaining to efficacy (specifically primary and major secondaryefficacy endpoints) and safety (specifically, serious adverse events asdefined in federal guidelines) have been independently confirmed by abiostatistician who is not employed by the corporate entity (the nameof the biostatistician must be provided); and

— A statement from the corresponding author that he or she had fullaccess to all of the data and takes full responsibility for the veracity ofthe data and analysis. All authors for each manuscript will also need to



29

complete and submit to the Journal’s editorial office the AuthorshipResponsibility portion of the Copyright Assignment, AuthorshipResponsibility, NIH Funding, Financial Disclosure, InstitutionalReview Board/Animal Care Committee Approval, and Sponsorshipform upon submission of a manuscript.

Authors must describe the role of the study sponsor(s), if any, in the study design; inthe collection, analysis, and interpretation of data; in the writing of the report; and in thedecision to submit the report for publication.

II. Reviewers and EditorialistsReviewers and editorialists will be disqualified from reviewing or from writing an

editorial if they: — have had an ongoing collaboration, original publications or grants

with the authors within the previous two years, except in the case ofbeing a part of a multi-center group from a different site; or

— are from the same institution as the authors.Reviewers and editorialists should disclose at the time of submission of their review or

editorial any financial arrangement (e.g., consultancies, stock ownership, equity interests,patent-licensing arrangements, research support, major honoraria, etc.) they may havewith a company whose product figures prominently in the submitted manuscript or witha company making a competing product. Interactions that occur from the start of theresearch activity in the specific program until the time when the paper is anticipated tobe published or one year from submission date, whichever is longer, are pertinent.

AuthorshipEach author must have participated sufficiently in the work to take public

responsibility for the content of the paper and must approve of the final version of themanuscript. Authorship should be based on substantive contributions to each of thefollowing:

— conception and design of the study;— generation, collection, assembly, analysis and/or interpretation of data;— drafting or revision of the manuscript;— approval of the final version of the manuscript.

National Institutes of Health (NIH) FundingIf a manuscript is accepted for publication and was supported in part, or in whole, by

the NIH, the author may request that the manuscript be automatically posted toPubMed Central (PMC). If the author wishes to make this request, he or she shouldcheck the appropriate box located on the Copyright Assignment Form under the NIHFunding portion of the form. In addition, the author must provide the NIH grantnumber. If an author makes this request, the manuscript will automatically be entered inthe PMC system and will be available to the public, free of charge, 12 months from themanuscript’s publication date.

Manuscript PreparationAuthors are asked to have their manuscript saved in Rich Text Format (.rtf) and each figure

saved as a separate electronic file, preferably named as “figure 1.tif,” “figure 2.jpg,” etc. — Image File Formats: We support the following among dozens of file

formats: .bmp, .gif, .jpg, .pbm, .pcx, .png, .tif, .eps, and .xbm, alongwith TARGA and Photoshop files. (ChemDraw, Excel, PowerPoint,SigmaPlot, and Equation Editor formats are not supported at thetime.) Your file formats can be mixed.

— Tables: Tables should be prepared without the use of tabs; most tableeditor programs can be uploaded successfully.

Arrange manuscript as follows, each component beginning on a separate page: — 1. Title page— 2. Abstract— 3. Introduction— 4. Materials and methods— 5. Results— 6. Discussion— 7. References— 8. Figures and figure legends— 9. Tables.

Place page number and first author’s last name at top of each page. Cite references, tables, and figures consecutively as they appear in the text. Authors are responsible for applying for permission for both print and electronic rights

for all borrowed materials and are responsible for paying any fees related to theapplications of these permissions.

Title PageTitle: Include animal species. Use no abbreviations. Limit: 120

characters with spaces.Short Title: Limit: 45 characters.Authors: Include first names of all authors and name and full location of

department and institution where work was performed.Grant Support: List grant support and other assistance.Abbreviations: List alphabetically abbreviations not mentioned in the Style

Guide, which follows the Instructions to Authors. (Note: Ingeneral, the use of abbreviations is discouraged.)

Correspondence: Provide name, complete address, e-mail address, telephonenumber, and fax number of corresponding author.



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AbstractLimit: 250 words. Organize according to the following headings: Background & Aims,

Methods, Results, and Conclusions.Do not use abbreviations, footnotes, or references.Authors of clinical research studies should submit a structured abstract of no more than

250 words organized into the following categories as applicable:— Background & Aims: Describe the importance of the study and the

precise research objective(s) or study question(s).— Methods: Methods should include information on the following

aspects of study design when applicable. The methods section mayemploy subheadings at the discretion of the author.

— Design: describe the basic study design, e.g., randomizedcontrolled trial, cross sectional study, cohort study, case series,survey, etc. Source of all non-standard reagents need to beexplicitly stated.

— Setting: specify whether the study was conducted in a primary ortertiary care setting, in an ambulatory care clinic or hospital, inthe general community, etc.

— Participants: indicate the number of study subjects and how theywere selected, recruited, and assigned to the intervention

— Intervention: report the method of administration and durationof the intervention.

— Results: Provide the main outcomes of the study including confidenceintervals or P values. Report the absolute values and risk differences sothat readers can determine the absolute, as well as the relative, impactof the results.

— Conclusions: State only conclusions that are directly supported bythe evidence and the implications of the findings.

Body of PaperDescribe ethical guidelines followed (for human or animal studies); cite approval of

institutional human research review committee or animal welfare committee; describe indetail hazardous procedures or chemicals involved, including precautions observed.

Outline statistical methods used.When describing the results of hypothesis testing, report P values and/or confidence

intervals; avoid using phrases such as “not significant.”Identify drugs and chemicals used by generic name (if trademarks are mentioned,

manufacturer name and city are given).

ReferencesCite references in order of appearance in text using superscripted Arabic numerals.Cite personal communications and unpublished data directly in text without being

numbered.

Conform abbreviations to those used in Index Medicus.Conform style and punctuation to GGaassttrrooeenntteerroollooggyy requirements:

— Article (list all authors):13. Meltzer SJ, Ahnen DJ, Battifour H, Yokokota J, Cline MJ.Protooncogene abnormalities in colon cancers and adenomatous polyps.Gastroenterology 1987;92:1174-1180.

— Book:18. Day RA. How to write and publish a scientific paper. Philadelphia:Institute for Scientific Information, 1979.

— Article in Book:22. Costa M, Furness JB, Llewellyn-Smith IF. Histochemistry of theenteric nervous system. In: Johnson LR, ed. Physiology of thegastrointestinal tract. Volume 1. 2nd ed. New York: Raven, 1987:1-40.

TablesTables should be prepared without the use of tabs; most table editor programs can be

uploaded successfully.

FiguresImages: Images can be clinical, pathologic (gross or microscopic),

endoscopic, or radiographic. They should be of high quality (300dpi or greater, clear, and in good focus) and illustrate well thediagnosis.

Photographs: Photographs of identifiable patients must be accompanied bywritten permission to publish from the patient.

Line art & graphs: Graphs, charts, and other line art will be redrawn by our MedicalIllustration Department for consistency with the overall style ofthe AGA Institute journals. Please be sure that any graphs or lineart you submit is at a resolution of at least 150 dpi so that they arereadable to reviewers.

Figure legends: Please do not embed or flatten the text into the image files.Figure legends should be typed and submitted in .rtf (rich textformat). This text will be reformatted in the style of the AGAInstitute journals.

Accepted figure file formats: We support the following among dozens of file formats: .bmp,

.gif, .jpg, .pbm, .pcx, .png, .tif, .eps, .xbm, .psd, and .tga files.When sending image files, please do not embed them in Word orPowerPoint. You may submit mixed file formats (image1.jpg,image2.tif, image3.eps, etc.).

Preferred figure file formats: .tiff and .psd. If you have created Photoshop image files

containing separate layers with arrows or text, please send us thelayered files (unflattened).



33

Image file formats not supported at this time: ChemDraw, CorelDraw, Canvas, FreeHand, Excel, PowerPoint,

SigmaPlot, and Equation Editor. You may export image files fromthese programs as PDF, Jpeg, or other acceptable file formats.

File naming convention: Figures should be named consecutively such as “figure 1.tif,”

“figure 2.jpg,” etc., with the file extension appended (.tif, .jpg,.eps, etc). Each figure should be saved as a separate electronic file.

Color Space: Color files should be submitted in the CMYK color space.Authors are encouraged to present color figures in a manner thatwill allow the data to be interpreted by colorblind readers.GGaassttrrooeenntteerroollooggyy suggests that authors present dual-labeled imagesin green and magenta rather than in green and red. See thewebsite of the Jfly data depository for Drosphila researchers(http://jfly.iam.u-tokyo.ac.jp/color/ ) for more information onhow to make figures and presentations intelligible for acolorblind audience.

Font: If your figures include text, an 8 to 10 point font should be used.Acceptable fonts are “sans serif” fonts such as Arial, Helvetica,and Myriad. Examples of unacceptable fonts (“serif” fonts) areTimes, Palatino, and Georgia. Lettering should begin with anupper case letter, followed by lower case lettering.

Multiple panel figures: Do not mount multiple part figures. Please submit each panel

(image) separately. However, you may submit a multiple panelversion to suggest the order in which you would like the panelsarranged. You may also include a written, suggested layout. Eachindividual panel should be of the highest possible quality (300 dpior higher) at actual print size.

CopyeditingManuscripts are copyedited to make them consistent with Journal style; if a particular

section in the manuscript is not clear or requires additional information, the copy editorwill direct questions to the author. These questions, or “author queries,” will appear inthe margins of the proofs that are sent to the author.

APPENDIX - D: AGA INSTITUTE

CME QUESTIONS AND LEARNING

OBJECTIVES WRITING GUIDELINES

Please refer to Constructing Written Test Questions for the Basic and ClinicalSciences, Third Edition provided by the National Board of Medical Examiners (NBME)as your guide for item writing. This guide can be reviewed atwww.nbme.org/about/itemwriting.asp.

Item WritingAll questions are to be original questions written in multiple-choice format. They

consist of the stem (question) and lead-in (instructing the examinee on how to approachthe answer, e.g., “Which of the following is the most likely diagnosis” or “Which of thefollowing is the most likely explanation for the findings”). Below are some quick tipsbased upon information provided from NBME’s publication on item writing.

— Write using “one best answer” format; examinees select the single bestresponse

— Provide 5 answers, A – E (1 correct, 4 incorrect distractors); do notinclude “none of the above,” “all of the above” as distractors

— Avoid negative formats (e.g., “Each is correct EXCEPT”, “Which isthe LEAST LIKELY”, “Which one of the following is NOT correct).

— Avoid True or False items — Items must be written at the 2nd-year trainee level — Each stem should not exceed 5 lines — Distractors must be plausible and written consistently with other

answer choices; no “trick” answers — Eliminate extraneous commentary about the patient, unless it impacts

diagnosis— Eliminate reference to race or ethnicity, unless it impacts diagnosis— Use “male” or “female” terms when referring to gender — Avoid ambiguity. The item must be written to clearly express the

intent of the item objective. Also, avoid over using abbreviations. — Be specific with the lead-in. Use precise terms to indicate what action

is required, e.g., “which of the following ….” or “what is the most …,”etc. See page 40 of the Item Writing Guide.

— Avoid cueing, e.g., leading the student to the answer, e.g., — by including the answer within the question— providing implausible distractors, or— through grammatical inconsistencies in the stem and distractors.

See page 41 of the Item Writing Guide.— Use of Case Clusters (as referenced on Page 43 of the Item Writing


AGA Institute Practice Rcommendations Development Manual0907

35

Guide). These are questions that present a scenario on which two ormore questions are asked as follow-up. Take care to construct theseitems. As opposed to “stand-alone” items, case clusters are typically“all-or-nothing” items in terms of scoring. If an examinee lacks theskill set or knowledge required, they will likely answer all the itemsincorrectly that are related to the patient care scenario. Wherepossible, you may elect to rework the case cluster to determine if theindividual items can be reworded as a single question, but still meetthe author’s objective.

Item ObjectiveBriefly identify your goal for the item. What knowledge or skill does the item try to

assess? This will help us identify whether the item is constructed effectively so that theexaminee has the best opportunity to correctly answer the question.

Item ClassificationThe following information is critical in helping us ensure the reliability and validity of

the items. This information will also assist us in providing analytical feedback toexaminees and training programs. Primary Category (according to ABIM Gastroenterology Blueprint)

— Identify the primary category or content area as: Liver, Colon,Stomach and duodenum, Esophagus, Pancreas, Small Intestine, Biliarytract, General

Cognitive Mechanism (2) — Knowledge (recall of basic facts or terms)— Application (problem resolution, critical thinking)

Rationale— For purposes of validity, briefly justify your choice of the correct answer

Documentation— Identify an authoritative reference for the material (e.g., a

gastroenterology textbook, the Core Curriculum, a journal article.Chapter and page citations are necessary. This information assists inensuring validity (the items are appropriate to the exam and that theanswers are justified through published material).

WRITING A TEST ITEMThe following is an example of how to write a test question for journal CME exams.Stem A previously healthy 32-year-old athlete is brought to the emergency

room because of melena and a fainting episode. His blood pressure isfound to be 70mm Hg palpable. The emergency room physician callsand asks you to immediately perform endoscopy.

Lead Line What is the best response at this point?

Response Options A. Ask the gastroenterology nurse to meet you immediately in theemergency room.

B. Start hemodynamic support immediately and pass a nasogastrictube to assess for evidence of bleeding.

C. Place a nasogastric tube and if the return is clear, schedule thepatient for EGD next week.

D. Start high-dose intravenous H2 blockers and give 30cc ofantacids via the nasogastric tube.

E. Consult with the ER physician.

Rationale When gastrointestinal bleeding is suspected, the most importantstep is to assess the severity of the bleed.1 This can be best gaugedby the overall hemodynamic status of the patient. Nasogastrictube aspirate can further identify patients with increased risk ofrebleeding or mortality. However, nasogastric tube aspirate is notaccurate in identifying patients who have stopped bleeding or areactively bleeding. Hemodynamic support should take precedencerather than diagnostic procedures. In a patient with a majorgastrointestinal hemorrhage, as identified by clinical criteria,endoscopy should be performed promptly when thehemodynamic status is stable.2

References 1. Cuellar, RE, Gavaler GS, Alexander GA et al. Gastrointestinalhemorrhage: the value of a nasogastric aspirate. Arch Intern Med1990, 150:1381-1412.

2. National Institutes of Health Consensus Developmentconference. Therapeutic endoscopy and bleeding ulcers. JAMA1989; 262:1369-1372.

A test item consists of a question, a set of responses, a critique, and references. Theitems are referable to the corresponding article. Answers should be in a multiple-choicequestion format throughout. In this format, one best answer is to be selected from a listof five options. The options are one correct answer and four distracters. The critiqueexplains the correct option, and why the other options are not correct, citing anyappropriate references drawn from the article reference list.

one correctresponse andfour distracters

(referencenumbers keyedto chapterreference list)

(will not appearwith test item)


The QuestionFormulating an educational objective for a question is the best way to get started.

Think of an objective before writing each item. Consider what the participant will beable to recognize, conclude, identify, etc.

After the objective of a question is clear, devise the stem of the question. This can be avignette, a statement of clinical background, or other information to provide a setting forthe question. The stem may convey patient history, examination findings, test results, orother relevant data. Avoid reference to race or ethnicity unless it impacts diagnosis anduse male or female terms when referring to gender. It does not need to be long andcomplex – too much information can lead to a loss of focus. Not all stems need to be castin the form of clinical vignettes. Instead, simple, concise statements concerning a singlearea of knowledge can be effective learning vehicles.

The Lead LineThe actual question is stated in a lead line. The question must be specific, and in a

form that can be answerable without the need to look at the response options. Avoid leadlines based solely on factual recall. Avoid vague terms such as rarely, occasionally,frequently, etc. Also avoid negative lead lines such as, “What is least likely,” “All optionsare appropriate except,” or “An outcome never seen is.” Do not include true or falseitems. Here are some examples of lead lines.

— What is the most likely explanation of these findings?— The most likely cause of this patient’s pain is:— What is the most likely complication of this patient’s condition?— This condition is most likely to progress to:— Given the test results, what is the most likely additional finding?— What is the most appropriate next step in establishing a diagnosis?— Which laboratory study is most likely to confirm the diagnosis?— What is the first priority in caring for this patient?— What is the most appropriate next step?— What is the most effective management strategy?

Response OptionsFive lettered response options (A-E) follow the question stem. Only one option must

clearly be the correct answer to the lead-in question. The incorrect options, known asdistracters, must be plausible choices. Distracters may be partially correct, addressingcommon forms of mismanagement, but one answer must clearly be best. Distracters shouldnot include “None of the above” or “All of the above”. Good response options have:

1. Plausibility. All distracters should be a plausible answer to thequestion.

2. Authority. The correct options must be unambiguously superior to allother options.

3. Homogeneity. All options should be homogeneous, consisting of thesame type of laboratory findings, diagnosis, treatment protocols, etc.

AGA Institute Practice Rcommendations Development Manual0907

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4. Comparability. All options should have the same grammatical structure,use consistent language and be of similar length and complexity.

In devising options, avoid mixing and clueing. Mixing may distract participants byraising issues not relates to the question, for example mixing testing and treatmentalternatives in one set of options. Clueing may hint at or tip off the correct option, forexample, using the correct response of one question in the next question stem.

Correct Answer and RationaleThe rationale presents the correct answer to the question and explains why each

distracter is not correct. It functions as a teaching tool, reflecting the educationalobjective of the question, substantiating the correct response, and expanding on the topicas presented in the article chapter. The rationale may be structured

— with the correct answer first, followed by discussion of the distracters;— with discussion of the distracters first, followed by explanation of the

correct answer; or — by following the sequence of the response options.

Sometimes a single paragraph suffices to address all the options. However, an openingparagraph may be useful to identify the problem and set the context for discussion. Also,the relatedness of content may dictate additional paragraphing.

ReferencesThe rationale should be supported by relevant references (approximately 3-6).

Tips for Writing Learning ObjectivesLearning Objectives: You should include 3 learning objectives. These should appear

as follows:At the end of this activity, the successful learner should:

1.Learning objective2.Learning objective3.Learning objective

Suggested approach to developing specific learning objectives: Connect thestatement above with a clear word or phrase which communicates the performance bythe learning. For example: assess, compare, diagnose, differentiate, distinguish, establish,demonstrate, identify, interpret, translate, analyze, explain, integrate, formulate, evaluate.

— The following words and phrases are NOT appropriate because theyare open to many interpretations: know, understand, appreciate,believe, value, apply scientific knowledge to, develop a knowledge of).

Finish with the specifics of what the learner will be doing when demonstratingachievement or mastery of the objective. The entire objective is the intended outcome orresults of the instruction.


Continued on next page

Copyright Assignment. In consideration of the American Gastroenterological Association (AGA) Institute (the“AGA Institute”) taking action to review and credit the below-identified submission (the “Manuscript”), and forother valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the undersignedauthors and/or creators (the “Authors”), jointly and severally, hereby transfer, convey, and assign to the AGAInstitute, free and clear of any liens, licenses or encumbrances, the entire right, title, and interest in and to theManuscript throughout the world, including without limitation in and to any and all copyrights for theManuscript (including but not limited to rights to copy, publish, excerpt, collect royalties and make derivativeworks) in print, electronic, Internet, broadcast, and all other forms and media now or hereafter known, and forany and all causes of action heretofore accrued in Authors’ favor for infringement of the aforesaid copyrights, tohave and to hold the same unto the AGA Institute, its successors and assigns, for and during the existence of theaforesaid copyrights, and all renewals and extensions thereof. At any time and from time to time hereafter, theAuthors shall upon the AGA Institute’s written request take any and all steps and execute, acknowledge anddeliver to the AGA Institute any and all further instruments and assurances necessary or expedient in order tovest the aforesaid copyrights and causes of action more effectively in the AGA Institute. The Authors retain thenonexclusive permission to use all or part of the Manuscript in future works of their own in a noncompeting way,provided proper copyright credit is given to the AGA Institute. Should the AGA Institute finally determine thatit will not publish the Manuscript, the AGA Institute agrees to assign its rights therein back to the Authors.(Note: material prepared by employees of the federal government in the course of their official duties may notbe copyrightable.)Authorship Responsibility. I, the undersigned Author, certify that I have participated sufficiently in theintellectual content, the analysis of data, if applicable, and the writing of the Manuscript, to take publicresponsibility for it. I have reviewed the final version of the Manuscript, believe it represents valid work, andapprove it for publication. As an Author of this Manuscript, I certify that, except to the extent expressly creditedto others in the text of the Manuscript: the entire Manuscript is an original creation of the Authors; and none ofthe material in the Manuscript has been published previously, is included in another manuscript, or is currentlyunder consideration for publication elsewhere. I also certify that this Manuscript has not been accepted forpublication elsewhere, and that I have not assigned, licensed, or otherwise transferred any right or interest in theManuscript to anyone. Moreover, should the AGA Institute or the editors of GASTROENTEROLOGY requestthe data upon which the Manuscript is based, I shall produce it. Authors are responsible for applying forpermission for both print and electronic rights for all borrowed materials and are responsible for paying any feesrelated to the applications of these permissions.Institutional Review Board/Animal Care Committee Approval. I, the undersigned Author, certify that myinstitution has approved the protocol for any investigation involving humans or animals and that allexperimentation was conducted in conformity with ethical and humane principles of research.Sponsorship. I, the undersigned author, certify that I had full access to all of the data in this study and I takeresponsibility for the integrity of the data and the accuracy of the data analysis.

APPENDIX - E: COPYRIGHT ASSIGNMENT,AUTHORSHIP RESPONSIBILITY, NIH FUNDING,

FINANCIAL DISCLOSURE, INSTITUTIONAL REVIEW

BOARD/ANIMAL CARE COMMITTEE APPROVAL,AND SPONSORSHIP FORM


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____________________________________________________________Signature

____________________________________________ _______________Print Name Date

____________________________________________________________Signature

____________________________________________ _______________Print Name Date

Employer signature(s) as Author (required for works made for hire):

____________________________________________________________Employer

____________________________________________________________By (Signature)

____________________________________________ _______________Print Name Date

____________________________________________________________Signature

____________________________________________ _______________Print Name Date

____________________________________________________________Signature

____________________________________________ _______________Print Name Date

Employer signature(s) as Author (required for works made for hire):

____________________________________________________________Employer

____________________________________________________________By (Signature)

____________________________________________ _______________Print Name Date

� I, the undersigned Author, certify that I have no financialarrangements (e.g., consultancies, stock ownership, equityinterests, patent-licensing arrangements, research support, majorhonoraria, etc.) with a company whose product figuresprominently in the submitted manuscript or with a companymaking a competing product except as disclosed on a separateattachment. All funding sources supporting the work areacknowledged on the title page.

____________________________________________________________Signature

____________________________________________________________Signature

____________________________________________________________Signature

____________________________________________________________Signature

� I, the undersigned Author, certify that I have included on the titlepage of the manuscript any financial arrangements (e.g.,consultancies, stock ownership, equity interests, patent-licensingarrangements, research support, major honoraria, etc.) that I havewith a company whose product figures prominently in the submittedmanuscript or with a company making a competing product. Allfunding sources supporting the work are acknowledged on the titlepage.

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PRACTICE RECOMMENDATIONS DEVELOPMENT MANUAL