“EXPLICIT" EVIDENCE-BASED CLINICAL PRACTICE GUIDELINE RESOURCE KIT

Irritable Bowel Syndrome (IBS)
March 2003; FDA Addendum 4/04; Herbal Preparations 07/06;

NOTE: Restricted Use of Zelnorm Permitted—July 2007

On July 27, 2007, the U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.

• Key inclusion criteria include:
  • Women under the age of 55 years
  • Currently suffering with IBS-C or Chronic Idiopathic Constipation
  • No satisfactory response to other available treatments and/or patients who had satisfactory improvement of their symptoms with prior Tegaserod treatment
  Key exclusion criteria include:
  • History or current diagnosis of cardiovascular ischemic disease
  • Symptoms suggestive of cardiovascular ischemic disease
  • Presence of any cardiovascular risk factors according to NIH guidelines
  • Uncompensated depression or anxiety or suicidal ideation or behavior

To become part of this program, patients should contact their physicians to inquire about the protocol and evaluate if they meet the criteria.

At the origination of this guideline in 2003, Delfini had found there was sufficient evidence of benefit in favor of tegaserod as compared to placebo. When tegaserod was removed from the market, all information about tegaserod was removed from this site. At this time this information is still removed from this site until such time as the evidence is re-reviewed.

INTRODUCTION TO THE IBS GUIDELINE RESOURCE KIT

About the Kit
This kit contains information about the best available evidence at the date of this guideline on IBS diagnosis and treatment to assist you and your patients in making testing and care management decisions. Tools and tips are also included.

Our Approach (See the Guideline Documentation in Guideline Resource Information for details)
Our approach emphasizes evidence and patient-centered care. We used an “explicit” evidence-based methodology based on the principles and systematic methods for guideline development first conceptualized by David Eddy, MD, PhD, and operationalized by Michael Stuart, MD, during his career at Group Health Cooperative – a consumer-owned health care system in Washington State, renown for its quality care. This work was sponsored and funded by Novartis. Our approach to this work was to apply the same high and identical standards we apply to all our work and was modeled on prior work done without industry support.

Who We Are
Delfini Group, LLC is devoted to assisting others learn how to apply evidence- and value-based medicine principles in an easy-to-understand way through training, consultations, resources and tools. Detailed information about us is available at www.delfini.org where you can also access the guideline.

Guideline Resource Kit Contents

Guideline Resource Info
"Explicit” Evidence Based Clinical Practice Guideline Resource Information – March 2003: Guideline materials designed primarily for primary care physicians and other clinicians who diagnose and manage IBS in adult patients and for professionals who plan and implement clinical quality improvement projects. These materials may be useful “as is” or may be helpful as “seeds” for creating information and decision aids that meet local needs. Webpage — Guideline Resource Info & Algorithm. Download — [PDF]

For Patients & Clinicians
Information & Decision Aid for Adult Patients and Clinicians– March 2003: Decision support including information and resources on IBS, treatment options, drug risks and benefits, and general information about evidence-based medicine. Webpage — Info for Patients & Clinicians. Download — [PDF].

The Science
References, Systematic Review Summaries and Basics on EBM: Research used in the guideline including critical appraisals of key scientific work used in developing the original guideline materials along with an EBM page for consumers. Webpage — The Science. Downloads — Treatment [PDF]; Diagnosis [PDF]; Communications [PDF]. (New evidence after 2003 appears within the guideline materials in the downloads.)

Implementation Tips
Implementation and Communication Tool: Ideas and tips for clinical practice change. Webpage — Implementation Tips. Download — [PDF]

Impact Assessment
Impact Assessment Template & Sample: Spreadsheet template included as an optional, customizable aid designed to help health care organizations project potential changes which may result from successful guideline implementation. A completed tool is included as an example and was constructed using assumptions generated through meetings with national medical leaders. Overwrite these assumptions to reflect your own along with your local conditions. Use to perform sensitivity analyses. Useful, when modified, for other clinical improvement projects. Click here to download the sample tool — Impact Assessment Template [Excel]

Acknowledgements
We extend special thanks to Novartis Pharmaceutical Corporation for support and sponsorship; our colleagues at EBMed – especially David Bjorkman, MD, MSPH (HSA), SM (Epid); Walter Peterson, MD; Debra Palestina, Executive Director; and Lyn Bowen, Project Manager; and Fanizzi Associates, especially Patti Robinson, Senior Project Manager and Kate Brown, Meeting Planner.