PROMs

Patient-Reported Outcome (PRO-2) - Crohn's disease outcome measure Flow

Patient-Reported Outcome - Crohn's disease outcome measure flow

Introduction

The PRO2 is a Patient-reported outcome derived from the Crohn's Disease Activity Index (CDAI) and determines the current severity of Crohn’s disease[1,2].

Calculation of the PRO2 was implemented as agreed upon by AZ Delta, AZ Maria Middelares and Imelda. Specifications can be found in this file

The Patient-Reported Outcome - Crohn's disease outcome measure flow contains the Patient-Reported Outcome (PRO-2) - Crohn's disease outcome measure questionnaire and associated calculation. After form submission, the Patient-Reported Outcome - Crohn's disease outcome measure calculation is executed automatically. It's easy to extend this flow with conditional logic based on the interpretation of the Patient-Reported Outcome - Crohn's disease outcome measure calculation.

Patient-Reported Outcome (PRO-2) - Crohn's disease outcome measure questionnaire

Questions and Scoring

A subscore for Stool Frequency (SF) and Abdominal Pain (AP) is calculated by summing the weighted scores for these categories. The total score is the sum of all weighted scores.

Remission is determined as follows:

  1. SF & AP subscore <= 11 AND
  2. Raw SF score (unweighted) <= 3 AND
  3. Raw AP score (unweighted) <= 1

Result is a "0" or a "1" and can be interpreted as follows:

  • 0 = No remission
  • 1 = Remission

References

[1] Jairath V, Khanna R, Zou GY, Stitt L, Mosli M, Vandervoort MK, D'Haens G, Sandborn WJ, Feagan BG, Levesque BG. Development of interim patient-reported outcome measures for the assessment of ulcerative colitis disease activity in clinical trials. Aliment Pharmacol Ther. 2015 Nov;42(10):1200-10. doi: 10.1111/apt.13408. Epub 2015 Sep 21. PMID: 26388424.\
[2] Marin J. de Jong et al. Patient-Reported Outcome Measures for Use in Clinical Trials and Clinical Practice in Inflammatory Bowel Diseases: A
Systematic Review. Clinical Gastroenterology and Hepatology 2018;16:648–663.\
[3] Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology. 1976 Mar;70(3):439-44.

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