| 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 original 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).
Delfini has received
no further funding since the development of the guideline, but continues
to update it as a public service.
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.
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