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Introduction [PDF]
Guideline Resource Information & Algorithm [PDF]
Information for Patients & Clinicians [PDF]
The Science: Treatment [PDF]
The Science: Diagnosis [PDF]
The Science: Communications [PDF]
Implementation Tips [PDF]
Impact Assessment Template [Excel]

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Guideline Documentation
Introduction, Background and Scope of the Irritable Bowel Syndrome (IBS) Guideline: Irritable Bowel Syndrome (IBS) is defined as “abdominal discomfort associated with altered bowel habits”(2). IBS is a common condition with a prevalence of 10%-15% in North America and frequently causes a significant decrease in quality of life. Go to the Algorithm to see Guideline Exclusions and Notes.

Experts, published papers and textbooks vary widely in their recommendations regarding diagnostic testing and management of IBS. The objective of this explicit, evidence-based clinical guideline is to assist clinicians, patients and others who have uncertainty and knowledge gaps in the areas of diagnosis and management of IBS to better understand the current best-available evidence regarding IBS and to improve their management of uncomplicated IBS.

The Impact Assessment Template included in this resource kit is an optional, customizable aid designed to help health care organizations reflect upon their current care practices for IBS and to assist with projecting potential changes in quality of life, satisfaction and cost resulting from successful local implementation of the guideline. This tool is meant only to give organizations ideas for how they might approach assessing costs and other changes. If the template will be used directly to input organizational data, it is highly recommended that modifications be made by a staff person experienced both in Excel and in creating formulas. Any computations resulting from changes should be examined closely for accuracy.

Guideline Development Team
• Michael E. Stuart, MD, President, Delfini Group, LLC, and Clinical Assistant Professor, Department of Family Medicine, School of Medicine, University of Washington
• Sheri Strite, Principal & Managing Partner, Delfini Group, LLC, and, at the time of original guideline development, Associate Director, Program Development, Department of Family Medicine, School of Medicine, University of California, San Diego

Guideline Development Process: An “explicit” evidence-based process using the 4 “A”s (Ask • Acquire • Appraise • Apply) was used to develop this clinical guideline during March 2003; additions were made on 07/06 for herbal preparations, and 04/07 due to a medication withdrawal from market.

• Ask: Questions regarding natural history, prognosis, diagnosis, non-drug and drug therapy, and follow-up were addressed to the medical literature (see Search Strategy below).

• Acquire/Appraise: Studies were filtered excluding case series, editorials and opinions. Meta-analyses and systematic reviews without lethal threats to validity were prioritized and utilized when possible. RCTs were used when published subsequent to systematic reviews or when systematic reviews were not available. The evidence was evaluated for relevance and internal validity, and evidence summary documents were developed for the best available evidence.

• An evidence grading methodology was used to filter and grade the evidence for validity and usability. See Guideline Notes and also Delfini Information & Decision Aid for Patients and Practitioners.

• Guideline recommendations were based on systematic reviews, and RCTs when available, but expert opinion was utilized in parts of the guideline when evidence was not available or not usable because of threats to validity. The strength of the evidence is noted in the guideline and decision support.

• Guideline Decision-Making Process: All decisions were made by consensus using the best-available evidence along with expert opinion when evidence was not sufficient to guide recommendations.

• Guideline Peer Review: The guideline was reviewed for relevance and validity by –

— David Bjorkman MD, MSPH, SM, Professor of Medicine, University of Utah School of Medicine
— Walter Peterson, MD, Professor of Medicine, University of Texas Southwestern School of Medicine and co-editor of Alimentary Pharmacology and Therapeutics
— Following guideline development, we also invited comments from a gastroenterologist medical director at Novartis and accepted those changes we independently deemed to be guideline improvements
— We are also grateful to various medical leaders and other participants of the community practice meetings who contributed their input and made suggestions.

Funding: Delfini Group, LLC, was invited by Novartis to independently develop an evidence-based clinical guideline. Prior to agreeing, and at risk without compensation, Delfini first evaluated the evidence available for IBS, basing a decision to proceed only upon meeting rigorous requirements 1) that there be sufficient valid and relevant evidence available, 2) that there be sufficiently important results (e.g., statistical significance, clinical relevance and patient-centeredness), and 3) which Delfini agreed would be a guideline worth developing, irrespective of any remuneration. This guideline is based on the principles and rigorous, systematic methods for “explicit” evidence-based guidelines first conceptualized by David Eddy, MD, PhD, and subsequently operationalized and used by Dr. Michael Stuart during his career at Group Health Cooperative in Seattle, Washington. Delfini has licensed this guideline to Novartis Pharmaceuticals, manufacturer of Zelnorm (tegaserod).

Potential Conflicts of Interest: See Funding. We believe this guideline has been developed with no conflict of interest and stand fully behind it based on precepts of the most rigorous practice of evidence-based medicine and the “explicit” guideline development method. Even when basing recommendation on evidence-based medicine principles, a great deal of judgment is necessary. This method is highly transparent, aiding in reproducibility, validity assessment and evaluation, and as such, this method is an aid to expected differences in judgment.

We believe our biases are toward critically appraised evidence with meaningful results and toward patient-centeredness. We believe that “value” and other issues should generally be assessed locally due to variations in local circumstances and also because we believe patients should have information about evidence-based options regardless of coverage.

We believe the guideline, itself, supports our evidence and patient-centered approach:
1. We believe our process is highly transparent, and it is fully documented for replicability.
2. The evidence stands on own and is available to others for review.
3. We have demonstrated our preference for first trying low risk/low cost options despite lack of high quality evidence.
4. We have attempted to present information in a fair and balanced way (averaging NNTs for example).
5. While at Group Health, Dr. Stuart implemented a guideline which significantly decreased the use of diagnostic testing where there was no good evidence for such testing. Hence the recommendations in this guideline are consistent with his past approach.
6. Much of the language used in the guideline and decision support is identical to, or consistent with, language we have previously used in similar work that is unfunded – and which we make publicly available.
7. We have demonstrated our preference for a conservative approach to drug use, consistent with our approach for similar, unfunded work.

Search Strategies: The National Library of Medicine (PubMed, OVID) were searched from 1970-Feb, 2003 using the search terms listed below. Search Limits and Clinical Queries in PubMed were utilized. Bibliographies were hand-searched.

Natural History, Prognosis: Search strategy included combinations: MeSH Terms, Epidemiology, Etiology, Language, and Text Word, colonic diseases, functional, irritable bowel syndrome, adult, colonic diseases, Meta-Analysis, English, Practice Guideline, Systematic Review.

Diagnosis: Search strategy included combinations: MeSH Terms, Text Word, colonic diseases, functional, irritable bowel syndrome, Meta-Analysis, English, adult, Practice Guideline, diagnosis, systematic review, blood, parasite, stool analysis, radiography, hydrogen breath testing, thyroid function, sedimentation rate, endoscopy, barium enema, colonoscopy, flexible sigmoidoscopy.

Management, Follow-up, Therapy: Search strategy included combinations: MeSH Terms, Text Words, clinical trial, randomized, Meta-Analysis, English, adult, Diet Therapy, Drug Therapy, Therapy, Colonic Diseases, Practice Guideline, self-management, systematic review, communication, bedside manner, rapport, physician-patient relationship, medical interview, adherence, understanding, patient-understanding, compliance, satisfaction, antispasmodic, antimuscarinic, diet, smooth muscle relaxant, dicyclomine, hyoscyamine, constipation, fiber, polycarbophil, bulking agents, laxative, antidepressant, tricyclic antidepressant, tegaserod, alosetron, antidiarrheal agents, loperamide, lomotil, simethicone, behavioral therapy, colonic diseases, functional , irritable bowel syndrome.