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News

Patient-reported outcome measures for use in IBD trials

A study in the most recent issue of Clinical Gastroenterology & Hepatology examines patient-reported outcome measures for use in IBD trials and clinical practice.

News image

Mucosal inflammation must be carefully monitored to improve the long-term outcomes of patients with inflammatory bowel diseases (IBD). 

Patient-reported outcome measures are used increasingly to monitor disease activity in clinical practice and as endpoints in clinical trials. 

Dr Marin de Jong and colleagues performed a systematic review to provide an overview of the available patient-reported outcome measures on IBD activity and to evaluate their diagnostic value.

The team performed a systematic search of the PubMed, Medline, Cochrane library, and Embase databases using defined keywords, and identified 973 articles. 


17 articles were identified, presenting 20 different patient-reported outcome measures
Clinical Gastroenterology & Hepatology
These were screened by 2 independent reviewers, and 37 articles on development or validation of patient-reported outcome measures to assess IBD activity were identified for further analysis. 

Based on the recommendations of the Food and Drug Administration (FDA), the following measurement properties were evaluated: content, construct, and criterion validity; reliability; and responsiveness to change. 

In addition, data on ease of use in clinical practice were collected.

The research team included 17 articles presenting 20 different patient-reported outcome measures, although none met all the FDA-recommended criteria. 

Only 2 reported patient involvement during its development. 

The researchers found that only 6 patient-reported outcome measures were validated as markers of IBD activity, using findings from endoscopy as the reference standard.

The team observed that these patient-reported outcome measures identified patients with mucosal inflammation with area under the curve values of 0.63–0.82. 

The mobile health index for CD and UC scores had the best measurement properties for use in clinical practice and in clinical trials.

Dr de Jong's team comments, "In a systematic review, we identified more than 20 patient-reported outcome measures that have been developed and tested for their ability to determine IBD activity."

"Further studies are needed to determine their accuracy and whether they can be used effectively in routine practice, clinical trials, telemedicine systems, and value-based healthcare programs."

Clin Gastroenterol Hepatol 2018: 16(5): 648–663.e3
24 May 2018

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