Diary for Irritable Bowel Syndrome Symptoms—Constipation (DIBSS-C)

OVERVIEW

The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) has determined that the measures of abdominal pain, abdominal symptoms (abdominal pain, discomfort, bloating), complete spontaneous bowel movement (CSBM) frequency, and straining with bowel movements (BMs) from the Diary for Irritable Bowel Syndrome Symptoms—Constipation (DIBSS-C) have demonstrated adequate evidence of content validity and cross-sectional measurement properties (i.e., internal consistency reliability, test-retest reliability, convergent validity, and known-groups validity) for the following context of use. The qualification statement supports the DIBSS-C weekly abdominal pain intensity score, weekly abdominal symptoms domain (abdominal pain, discomfort, bloating) score, weekly complete spontaneous BM frequency, and weekly straining with BMs score as measures of their respective concepts to derive efficacy endpoints in drug development clinical trials for products intended to treat irritable bowel syndrome with constipation (IBS-C) in adults. Further evaluation is needed on the DIBSS-C’s longitudinal measurement properties (e.g., ability to detect change) and the interpretation of clinically meaningful within-patient change in scores. Sponsors seeking to use the DIBSS-C as a primary or secondary endpoint measure in confirmatory studies should discuss plans with the appropriate CDER review division. For additional details regarding FDA’s qualification statement, please visit FDA's Qualification Clinical Outcome Assessments site.

  • Measure Name: Diary for Irritable Bowel Syndrome Symptoms—Constipation (DIBSS-C)

  • Version: 1.0

  • Number of items: 7

  • Target patient population: Adults 18 years of age and older; males and non-pregnant females

  • Concept of interest: IBS sign and symptom severity

  • Recall period: Event-driven and 24-hour (end of day)​

  • Response scale: Verbal rating scales, bivariate response, 11-point numeric rating scales

  • Mode of data collection: Electronic administration is required for the DIBSS-C and previous studies were conducted using a handheld (e.g., smartphone) electronic device.

DIBSS-C  ITEMS
 

USER MANUAL

Available with license


LANGUAGE AVAILABILITY

Available translations of the DIBSS-C can be obtained when licensing the measure(s). To assure standardized translations, users are not permitted to translate the DIBSS-C without prior, written permission from the PRO Consortium. Please contact us for more details.

PREFERRED TRANSLATION VENDOR FOR DIBSS-C
FACITrans

LICENSING
Licensing fees are assessed on a per trial/per measure basis for commercial use.​

  • ​PRO Consortium Member Firms:

    • First Language​                                                                                           $1000 USD

    • Each Additional/Available Language                                                        $500 USD

  • Non-Member Organizations​

    • First Language​                                                                                          $4000 USD

    • Each Additional/Available Language                                                      $2000 USD

Non-commercial use is assessed on a case-by-case basis for appropriateness and applicability.

 

To license the DIBSS-C please complete the licensing form. All of the information provided in the form will be kept strictly confidential. For questions about the measure, please contact us.

PUBLICATIONS

Fehnel SE, Ervin CM, Carson RT, Rigoni G, Lackner JM, Coons SJ, on behalf of the Critical Path Institute Patient-Reported Outcome Consortium’s Irritable Bowel Syndrome Working Group. Development of the Diary for Irritable Bowel Syndrome Symptoms (DIBSS) to assess treatment benefit in clinical trials: foundational qualitative research. Value in Health 2017;20:618-626. (https://doi.org/10.1016/j.jval.2020.01.001)

 

Coon CD, Hanlon J, Abel JL, Lundy JJ, Carson RT. Psychometric analysis of the abdominal score from the Diary for Irritable Bowel Syndrome Symptoms–Constipation using phase IIb clinical trial data. Value in Health 2020;23:362-369. (https://doi.org/10.1016/j.jval.2020.01.002)