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The Process of Developing a Disease Activity Index in Microscopic Colitis
Katarina Pihl Lesnovska1, Andreas Münch1, Ole Bonderup2
1Department of Gastroenterology and Hepatology in Linköping, and Department of Health, Medicine, and Caring Sciences, Linköping University, Linköping, Sweden.
Background And Aims:
Patient-reported outcome measures [PROMs] aim to measure patients' perception of how their disorder influences everyday functioning. The objective of this study was to develop a PROM to assess disease activity in microscopic colitis [MC] fulfilling the requirements of the Food and Drug Administration [FDA].
Methods:
The European Microscopic Colitis Activity Index [E-MCAI] was developed in four steps. [1] A list of symptoms associated with active MC was created by a group of experts in the field. [2] Content validity of the symptoms was performed by experts [n = 14] and patients [n = 79] using the Content Validity Index. [3] Questions and response alternatives were created for each symptom, and validity of the E-MCAI was evaluated with cognitive interviews with patients [n = 7] and by the experts. [4] A pilot postal survey was performed to ensure usability.
Results:
Seven of the symptoms related to active MC fulfilled the criteria for content validity and were included in the E-MCAI: stool consistency, stool frequency, stools at night, feel a need to pass more stools shortly after a bowel movement, urgent need to empty the bowel, leakage of stool and abdominal pain. The development and validation process resulted in the current version of the E-MCAI consisting of six questions related to MC.
Conclusions:
The E-MCAI was developed using the methods advocated by the FDA. The evaluation indicates good content validity. Further evaluation will be performed to achieve construct validity, reliability and responsiveness in future cross-sectional and longitudinal studies.
Insights
A new patient-reported outcome measure, the European Microscopic Colitis Activity Index (E-MCAI), was developed to assess microscopic colitis disease activity. This tool shows good content validity and aims to meet FDA requirements for patient-reported outcome measures.
Area of Science:
- Gastroenterology
- Clinical Outcome Assessment
Background:
- Microscopic colitis (MC) requires patient-reported outcome measures (PROMs) to assess disease impact on daily life.
- Current PROMs may not fully meet regulatory standards for assessing MC disease activity.
Purpose of the Study:
- Develop a PROM for microscopic colitis disease activity assessment.
- Ensure the developed PROM aligns with Food and Drug Administration (FDA) guidelines.
Main Methods:
- The European Microscopic Colitis Activity Index (E-MCAI) was developed through expert and patient consensus.
- Content validity was established using the Content Validity Index with 14 experts and 79 patients.
- Cognitive interviews and a pilot survey refined the E-MCAI's questions and usability.
Main Results:
- Seven key symptoms of active MC demonstrated content validity: stool consistency, frequency, nocturnal stools, urgency, incomplete evacuation, leakage, and abdominal pain.
- The final E-MCAI comprises six questions, reflecting core aspects of microscopic colitis activity.
- The development process adhered to FDA-recommended methodologies.
Conclusions:
- The E-MCAI is a newly developed PROM for microscopic colitis.
- Initial evaluations indicate good content validity, meeting FDA development standards.
- Further studies are planned to establish construct validity, reliability, and responsiveness.
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