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Development of a Novel Tool to Assess the Impact of Itching in Pediatric Cholestasis
Binita M Kamath1, Linda Abetz-Webb2, Ciara Kennedy3
1Hospital for Sick Children and The University of Toronto, Toronto, ON, Canada. binita.kamath@sickkids.ca.
Insights
Researchers developed the Itch Reported Outcome (ItchRO) patient and observer diaries to assess itching in children with Alagille syndrome (ALGS) and other cholestatic liver diseases. These tools are crucial for clinical trials evaluating treatments for pediatric cholestatic pruritus.
Area of Science:
- Pediatric Gastroenterology
- Clinical Outcome Assessment Development
- Hepatology
Background:
- Itching (pruritus) is a significant and bothersome symptom in children with cholestatic liver diseases, including Alagille syndrome (ALGS).
- Existing clinical outcome assessments may not adequately capture the impact of itching in this pediatric population.
- Itching negatively affects patients' quality of life, leading to skin damage, mood changes, and sleep disturbances.
Purpose of the Study:
- To develop and validate a clinical outcome assessment (COA) specifically designed to measure itching in children experiencing cholestatic pruritus.
- To create reliable tools for both patient self-reporting and caregiver observation of itch severity and impact.
Main Methods:
- Prospective study involving patients with Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis type 1, and their caregivers.
- Qualitative interviews to confirm itching as a primary concern and guide diary development.
- Modification and cognitive debriefing of existing diaries with participants.
- Iterative revision of diary questions based on interim analysis and expert review.
Main Results:
- Itching was identified as the most bothersome symptom by ALGS patients and caregivers.
- Two versions of the Itch Reported Outcome (ItchRO) were developed: ItchRO(Patient) and ItchRO(Observer).
- The ItchRO diaries consist of a single, twice-daily scorable item for assessing itch, with high spontaneous reporting of itch by patients and caregivers.
Conclusions:
- The ItchRO(Patient) and ItchRO(Observer) are novel tools developed to assess itching in pediatric cholestatic liver diseases, particularly ALGS.
- These validated diaries will aid in evaluating the efficacy of interventions for pediatric pruritus in clinical trials.
- The ItchRO represents a significant advancement in measuring a key symptom impacting children with cholestatic conditions.
Objectives:
The aim was to develop a clinical outcome assessment (COA) for itching in children with cholestatic pruritus.
Methods:
This prospective study aimed to enroll patients aged 4-30 years with Alagille syndrome (ALGS) or progressive familial intrahepatic cholestasis type 1 and caregivers of patients aged 5 months to 14 years. Eligible patients experienced itching during ≥3 of the 7 days before enrollment and had not undergone liver transplant or surgical interruption of the enterohepatic circulation. Open-ended qualitative interviews confirmed that itching was a primary concern for patients and caregivers. Diaries were modified and then evaluated by participants during cognitive debriefing. Interview results were reviewed by clinical, COA and statistical experts. Diary questions were revised following an interim analysis before finalizing the Itch Reported Outcome (ItchRO).
Results:
Thirty-six interviews were analyzed, representing 25 families of patients with ALGS. Itching was reported spontaneously (without prompting by the interviewer) by ten of 12 patients with ALGS and 19 of 20 caregivers. Consequences of itching included skin damage (78%), mood changes (59%), and difficulties staying asleep (59%) or falling asleep (53%). Two versions of the ItchRO were developed: ItchRO(Patient) for self-completion by patients and ItchRO(Observer) for caregivers. The ItchRO diaries comprise a single scorable item to assess itch and are to be completed twice daily (morning and evening).
Conclusions:
Itching was the most bothersome ALGS symptom reported by study participants. We have developed the ItchRO(Patient) and ItchRO(Observer) to assess itching in children with ALGS and other cholestatic liver diseases. These diaries are being validated for use in clinical trials.
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