Primer to First Edition of Multi-Dimensional Clinical Profile (MDCP) For Functional Gastrointestinal Disorders A Rome Foundation Publication 2 | Primer to the Multi-Dimensional Clinical Profile Editor MAX J. SCHMULSON, MD DOUGLAS A. DROSSMAN, MD Professor of Medicine President, Rome Foundation Facultad de Medicina-Universidad Nacional Autónoma de Professor Emeritus of Medicine and Psychiatry, University México (UNAM) of North Carolina Laboratorio de Hígado, Páncreas y Motilidad (HIPAM)- Co-Director Emeritus, UNC Center for Functional GI and Departamento de Medicina Experimental Motility Disorders Hospital General de México President, Center for Education and Practice of Mexico City, Mexico Biopsychosocial Patient Care Drossman Gastroenterology PLLC MAGNUS SIMRÉN, MD, PhD Chapel Hill, NC, USA Professor of Gastroenterology Consultant, Department of Internal Medicine and Clinical Contributors Nutrition FERNANDO AZPIROZ, MD, PhD Institute of Medicine Chief, Department of Digestive Diseases Sahlgrenska Academy Professor of Medicine University of Gothenburg University Hospital Vall d’Hebron Gothenburg, Sweden Universitat Autonoma de Barcelona Barcelona, Spain ROBIN SPILLER, MD Professor of Gastroenterology LIN CHANG, MD Co-Director, Nottingham Digestive Diseases Biomedical Professor of Medicine Research Unit Oppenheimer Family Center for Neurobiology of Stress Nottingham Digestive Diseases Centre Division of Digestive Diseases University of Nottingham David Geffen School of Medicine at University of Queens Medical Centre California at Los Angeles Nottingham, UK Los Angeles, CA, USA JAN TACK, MD, PHD WILLIAM D. CHEY, MD, AGAF, FACP, FACG Professor of Medicine, University of Leuven Professor of Medicine Head, Department of Clinical and Experimental Medicine, Director, Gastroenterology Physiology Laboratory University of Leuven Co-Director, Michigan Bowel Control Program Head of Clinic Division of Gastroenterology Department of Gastroenterology University of Michigan University Hospital Ann Arbor, MI, USA K. U. Leuven TARGID (Translational Research Center for DOUGLAS A. DROSSMAN, MD Gastrointestinal Disorders) President, Rome Foundation Leuven, Belgium Professor Emeritus of Medicine and Psychiatry, University of North Carolina WILLIAM E. WHITEHEAD, PhD Co-Director Emeritus, UNC Center for Functional GI and Professor, Medicine & OBGYN Motility Disorders Director, UNC Center for Functional GI & Motility President, Center for Education and Practice of Disorders Biopsychosocial Patient Care University of North Carolina at Chapel Hill Drossman Gastroenterology PLLC Chapel Hill, NC, USA Chapel Hill, NC, USA JOHN E. KELLOW, MB BS, MD, FRACP Associate Professor Head of the Discipline of Medicine Sydney Medical School - Northern University of Sydney Sydney, Australia Copyright © 2015 by the Rome Foundation Contents A Rome Foundation Educational Product All rights reserved. No part of this book may be reproduced Editor’s Note 4 in any form or by electronic, online or mechanical means, including information storage and retrieval systems, Aim, Objectives and Rationale 4 Guidelines for Use of the MDCP 5 without permission in writing from the publisher, except Learning from the Case Reports 8 by a reviewer who may quote brief passages in a review. Use in Primary Care 8 Project Management, Book Design and Public Functional GI Disorders 8 Relations Functional Gastroduodenal Disorders 8 Ceciel Rooker Functional Dyspepsia (Postprandial Distress Publishing Consultant Syndrome); Moderate 8 Lynne Herndon Functional Bowel Disorders 10 Copy Editor Irritable Bowel Syndrome; Moderate 10 Jackie Mollenauer Functional Anorectal Disorders 12 Copy Assistants Functional Fecal Incontinence; Moderate 12 Kaylie Gibson, Tyler Westall Rome IV 14 Logo Design and Illustrations Jerry Schoendorf The Rome Foundation 15 Board of Directors 15 Educational Products 15 Sponsors 15 The Rome Foundation PO Box 6524 Raleigh, NC 27628 Phone − (919)787-5859 Fax − (919)900-7646 www.theromefoundation.org The Mission of the Rome Foundation To improve the lives of people with Functional GI Disorders The goals of the Rome Foundation are to: • Promote clinical recognition and legitimization of the functional GI disorders • Develop a scientific understanding of their pathophysiological mechanisms • Optimize clinical management for patients with FGIDs Rome Foundation Staff: Executive Director, Wink Hilliard Jr. Public Relations Director, Ceciel Rooker Public Relations Assistant, Tyler Westall Administrators, Michele Pickard, Claudia Rojas Medical Illustrator, Jerry Schoendorf Copy Editor, Jackie Mollenauer Website/Newsletter Design, Ceara Owre Trade Show Manager, Jamie DuMont Primer to the Multi-Dimensional Clinical Profile | 3 4 | Primer to the Multi-Dimensional Clinical Profile Aim, Objectives and Rationale Editor’s Note The Multi-Dimensional Clinical Profile This primer provides an introduction to the (MDCP) for Functional Gastrointestinal concept of the Multi-Dimensional Clinical Profile (GI) Disorders was developed to capture the (MDCP). It describes the MDCP, the criteria for wide range of clinical features of patients with FGIDs and to present the information the subcategories and a template for its use by in a manner that is patient specific and including three illustrative cases. After reviewing consistent with the thinking of experts in the field. this document, the reader will understand how to use the MDCP to develop clinical profiles for patients Aim: To develop a multi-component assessment system for that will permit more targeted treatment. FGIDs that can be used to characterize the full dimensionality of the patient’s illness state, and which will be applied in With publication of the MDCP book, we are beginning treatment planning and research. There are five dimensions: a new endeavor, one that will redefine the ways in A. The categorical Rome diagnosis (Category A); which clinicians can help patients having even the B. Additional information that subclassifies the diagnosis most complex functional GI disorders. Discerning leading to more specific treatments, e.g., IBS-D or clinicians are well aware that making a diagnosis of IBS-C; sphincter of Oddi dysfunction (SOD) I or II; IBS, functional dyspepsia, or functional abdominal functional dyspepsia EPS; or PDS (Category B); pain is not sufficient to determine treatment. Not all C. The personal impact of the disorder on the patient (Category C); patients with a diagnosis are the same. For example, D. Psychosocial influences (Category D); and a patient with IBS-D having mild and occasional E. Physiological abnormalities or biomarkers (Category E). symptoms of abdominal discomfort and loose stools and functioning without impairment would be treated Objectives: quite differently than a patient with the same diagnosis 1. To be useful in making valid treatment decisions within having continuous severe and disabling pain, and co- a variety of clinical settings morbid anxiety disorder with fears of incontinence 2. To have reliable categories when leaving the house. 3. To be accepted internationally by clinicians and investigators of various theoretical orientations The MDCP identifies and classifies these components 4. To be useful for educating trainees and health into a highly specific plan placed within a framework professionals that is targeted to the needs of the individual. The five 5. To maintain compatibility with and be accepted and/ components of this framework include the categorical or endorsed by ICD-10 and third-party payers (to be Rome diagnosis (Category A), additional information established) that subclassifies the diagnosis leading to more specific 6. To provide terminology, including psychiatric terms treatments (e.g., IBS-D or IBS-C, SOD I or SOD II, that are readily understood and obtained by non-mental- EPS or PDS), the personal impact of the disorder on health professionals the patient (Category C), psychosocial influences 7. To make efforts to reach consensus on the meaning of (Category D), and physiological abnormalities or the terms that previously have been used inconsistently and to avoid terms that have outlived their usefulness biomarkers (Category E). This framework is intuitively 8. When possible, to use information that has been clear and the organizational approach is both pragmatic obtained from research studies in order to provide a and useful. level of validation 9. To permit identification of subjects for use in research The MDCP book containing 32 patient cases is studies available for purchase at $29.95 USD or €20.00 EUR 10. To permit responsiveness to change over time based on online at http://www.romecriteria.org/shop.cfm, or by scientific evidence visiting the Rome Foundation booth in the exhibitor 11. To be amenable to future investigation and validation area at various medical conferences. Rationale: The diagnosis of FGIDs is based on a categorical Douglas A. Drossman, MD system that uses the Rome criteria. These criteria relate to President, Rome Foundation patient symptoms and (for some disorders) physiological On behalf of the Rome Foundation Board of Directors findings that occur around a pre-specified time frame. This categorical assessment system is helpful for selecting patients for clinical studies and treatment trials. However, there are limitations for using solely the criteria in clinical practice since this assessment system is not able to address: • Certain clinically meaningful subsets of these diagnoses, – Fatigue • Physiological contributions or degrees of impairment,