Symptom-based diagnostic criteria: A work in progress in IBS

CHICAGO – Symptom-based criteria provide a substrate to diagnose patients with irritable bowel syndrome, but these criteria have their own distinct limitations, according to Dr. Douglas Drossman.

They’re too cumbersome for clinical diagnosis, they don’t help clinicians determine the diagnostic pathway, and their time frame and frequency criteria prevent treatment of subthreshold symptoms, Dr. Drossman said at the meeting sponsored by the American Gastroenterological Association.

They’re also not precise enough to identify meaningful physiologic subgroups that might lead to more targeted treatment and don’t fully characterize the complex variability in clinical presentation.

“A patient with IBS in primary care is going to be very different than the patient with IBS in the referral setting. They oversimplify the dimensionality of the illness by just using criteria,” he added.

The Rome IV diagnostic criteria, which are due out in spring 2016, try to address some of these limitations by further simplifying some of the 2006 Rome III diagnostic criteria and creating clinical algorithms that provide clinicians with a pathway leading to diagnosis and subtyping.

To address the severity and variability of clinical presentation, a Multi-Dimensional Clinical Profile (MDCP) system has been created that incorporates diagnostic criteria with additional clinical, quality of life, psychosocial, and physiologic parameters to help create a more precise, individualized treatment plan for patients with functional gastrointestinal disorders, Dr. Drossman, president of the Rome Foundation, said.

“The rationale is that with the Rome criteria, you either have it or you don’t,” he explained. “It’s a categorical classification system. The MDCP augments the criteria by providing patient-specific information.”

The MDCP has five categories beginning with the diagnosis (category A), which can be made using traditional symptom-based criteria like the Rome diagnostic criteria, but may also include physiologic criteria.

Category B is the clinical modifiers that are not part of the diagnostic criteria such as IBS-C (constipation); IBS-D (diarrhea); IBS-M (mixed); postinfective IBS; sphincter of Oddi dysfunction I, II, or III; or FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) sensitivity.

“This is going to help you in terms of treatment by drilling down a bit on the symptoms,” Dr. Drossman said.

Category C is essentially a single quality of life question: “How do your symptoms interfere with life?” that results in a rating of mild, moderate, or severe.

Category D is psychosocial modifiers or comorbidities. They may be categorical like a DSM-IV diagnosis of anxiety or depression, dimensional like a Rome psychosocial red flag, or patient reported such as a history of abuse. But all can impact outcome and symptom presentation, Dr. Drossman said.

Category E is physiologic modifiers, like motility, that can alter the clinical expression of the condition, and also will include validated biomarkers that will allow clinicians to subspecify patients for a particular type of treatment.

Dr. Drossman provided several case examples to illustrate how the MDCP might play out in practice and observed that a free primer on the MDCP, which includes cases, is now downloadable from the Rome Foundation website.

Finally, the Rome Foundation formed a partnership with LogicNets to develop and deliver an online decision support system for the next generation of MDCP protocols. The interactive system will guide practitioners through the decision-making pathways of the MDCP and allow gastroenterology experts worldwide to weigh in on cases, he said. The target launch date for the new platform is planned to coincide with release of the second edition of the MDCP containing the Rome IV diagnostic criteria and diagnostic algorithms.

Dr. Drossman reported having no financial conflicts of interest.

[email protected]

On Twitter @pwendl

CHICAGO – Symptom-based criteria provide a substrate to diagnose patients with irritable bowel syndrome, but these criteria have their own distinct limitations, according to Dr. Douglas Drossman.

They’re too cumbersome for clinical diagnosis, they don’t help clinicians determine the diagnostic pathway, and their time frame and frequency criteria prevent treatment of subthreshold symptoms, Dr. Drossman said at the meeting sponsored by the American Gastroenterological Association.

They’re also not precise enough to identify meaningful physiologic subgroups that might lead to more targeted treatment and don’t fully characterize the complex variability in clinical presentation.

“A patient with IBS in primary care is going to be very different than the patient with IBS in the referral setting. They oversimplify the dimensionality of the illness by just using criteria,” he added.

The Rome IV diagnostic criteria, which are due out in spring 2016, try to address some of these limitations by further simplifying some of the 2006 Rome III diagnostic criteria and creating clinical algorithms that provide clinicians with a pathway leading to diagnosis and subtyping.

To address the severity and variability of clinical presentation, a Multi-Dimensional Clinical Profile (MDCP) system has been created that incorporates diagnostic criteria with additional clinical, quality of life, psychosocial, and physiologic parameters to help create a more precise, individualized treatment plan for patients with functional gastrointestinal disorders, Dr. Drossman, president of the Rome Foundation, said.

“The rationale is that with the Rome criteria, you either have it or you don’t,” he explained. “It’s a categorical classification system. The MDCP augments the criteria by providing patient-specific information.”

The MDCP has five categories beginning with the diagnosis (category A), which can be made using traditional symptom-based criteria like the Rome diagnostic criteria, but may also include physiologic criteria.

Category B is the clinical modifiers that are not part of the diagnostic criteria such as IBS-C (constipation); IBS-D (diarrhea); IBS-M (mixed); postinfective IBS; sphincter of Oddi dysfunction I, II, or III; or FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) sensitivity.

“This is going to help you in terms of treatment by drilling down a bit on the symptoms,” Dr. Drossman said.

Category C is essentially a single quality of life question: “How do your symptoms interfere with life?” that results in a rating of mild, moderate, or severe.

Category D is psychosocial modifiers or comorbidities. They may be categorical like a DSM-IV diagnosis of anxiety or depression, dimensional like a Rome psychosocial red flag, or patient reported such as a history of abuse. But all can impact outcome and symptom presentation, Dr. Drossman said.

Category E is physiologic modifiers, like motility, that can alter the clinical expression of the condition, and also will include validated biomarkers that will allow clinicians to subspecify patients for a particular type of treatment.

Dr. Drossman provided several case examples to illustrate how the MDCP might play out in practice and observed that a free primer on the MDCP, which includes cases, is now downloadable from the Rome Foundation website.

Finally, the Rome Foundation formed a partnership with LogicNets to develop and deliver an online decision support system for the next generation of MDCP protocols. The interactive system will guide practitioners through the decision-making pathways of the MDCP and allow gastroenterology experts worldwide to weigh in on cases, he said. The target launch date for the new platform is planned to coincide with release of the second edition of the MDCP containing the Rome IV diagnostic criteria and diagnostic algorithms.

Dr. Drossman reported having no financial conflicts of interest.

[email protected]

On Twitter @pwendl

CHICAGO – Symptom-based criteria provide a substrate to diagnose patients with irritable bowel syndrome, but these criteria have their own distinct limitations, according to Dr. Douglas Drossman.

They’re too cumbersome for clinical diagnosis, they don’t help clinicians determine the diagnostic pathway, and their time frame and frequency criteria prevent treatment of subthreshold symptoms, Dr. Drossman said at the meeting sponsored by the American Gastroenterological Association.

They’re also not precise enough to identify meaningful physiologic subgroups that might lead to more targeted treatment and don’t fully characterize the complex variability in clinical presentation.

“A patient with IBS in primary care is going to be very different than the patient with IBS in the referral setting. They oversimplify the dimensionality of the illness by just using criteria,” he added.

The Rome IV diagnostic criteria, which are due out in spring 2016, try to address some of these limitations by further simplifying some of the 2006 Rome III diagnostic criteria and creating clinical algorithms that provide clinicians with a pathway leading to diagnosis and subtyping.

To address the severity and variability of clinical presentation, a Multi-Dimensional Clinical Profile (MDCP) system has been created that incorporates diagnostic criteria with additional clinical, quality of life, psychosocial, and physiologic parameters to help create a more precise, individualized treatment plan for patients with functional gastrointestinal disorders, Dr. Drossman, president of the Rome Foundation, said.

“The rationale is that with the Rome criteria, you either have it or you don’t,” he explained. “It’s a categorical classification system. The MDCP augments the criteria by providing patient-specific information.”

The MDCP has five categories beginning with the diagnosis (category A), which can be made using traditional symptom-based criteria like the Rome diagnostic criteria, but may also include physiologic criteria.

Category B is the clinical modifiers that are not part of the diagnostic criteria such as IBS-C (constipation); IBS-D (diarrhea); IBS-M (mixed); postinfective IBS; sphincter of Oddi dysfunction I, II, or III; or FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) sensitivity.

“This is going to help you in terms of treatment by drilling down a bit on the symptoms,” Dr. Drossman said.

Category C is essentially a single quality of life question: “How do your symptoms interfere with life?” that results in a rating of mild, moderate, or severe.

Category D is psychosocial modifiers or comorbidities. They may be categorical like a DSM-IV diagnosis of anxiety or depression, dimensional like a Rome psychosocial red flag, or patient reported such as a history of abuse. But all can impact outcome and symptom presentation, Dr. Drossman said.

Category E is physiologic modifiers, like motility, that can alter the clinical expression of the condition, and also will include validated biomarkers that will allow clinicians to subspecify patients for a particular type of treatment.

Dr. Drossman provided several case examples to illustrate how the MDCP might play out in practice and observed that a free primer on the MDCP, which includes cases, is now downloadable from the Rome Foundation website.

Finally, the Rome Foundation formed a partnership with LogicNets to develop and deliver an online decision support system for the next generation of MDCP protocols. The interactive system will guide practitioners through the decision-making pathways of the MDCP and allow gastroenterology experts worldwide to weigh in on cases, he said. The target launch date for the new platform is planned to coincide with release of the second edition of the MDCP containing the Rome IV diagnostic criteria and diagnostic algorithms.

Dr. Drossman reported having no financial conflicts of interest.

[email protected]

On Twitter @pwendl