Cholestatic pruritus, a frequently reported, debilitating symptom among patients with primary biliary cholangitis (PBC), is under-documented in patient medical records, according to a cross-sectional, noninterventional study on the topic was conducted among patients undergoing PBC care in the United States, with results published in BMJ Open Gastroenterology.
The medical records were compared with patient-reported responses on the PBC-40—a validated health-related quality-of-life (HRQoL) measure that includes 40 PBC-related questions distributed across six domains.
PBC is recognized as a rare, progressive, chronic autoimmune disorder that impacts women up to 9 times more often than men. Although prevalence of the condition varies according to locale, rates as high as 39.2 cases per 100,000 individuals in the United States have been reported. Untreated PBC can be associated with end-stage hepatic disease that requires liver transplantation. Among patients with PBC who are managed well, however, a nearly normal life expectancy is observed, with the main impact of the disorder linked to patients’ symptoms.
The researchers sought to evaluate the extent to which pruritus was documented in the medical records of individuals with PBC compared with patient-reported pruritus, as well as whether those patients who reported their itch as being mild had a lower likelihood of having their pruritus documented. The investigators also endeavored to depict the clinico-demographic profile of these individuals, including the recent use of treatments for PBC and pruritus, based on severity of pruritus. Further, they investigated the HRQoL of individuals with medical record–documented pruritus vs those with patient-reported pruritus.
The current study was conducted in patients who had received PBC care in the United States. These patients were invited to participate in the study by enrollment in the PicnicHealth PBC cohort between January 2021 and May 2022 via social media campaigns, patient advocacy groups, and affiliate partners.
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In this study, pruritus based on findings from medical records was identified according to the documentation of pruritus in either structured or unstructured data. Pruritus was further defined as “ever” (on, or at any point prior to, baseline) or “recent” (≥12 months prior to baseline).
Patient-reported pruritus was evaluated with utilization of the first PBC-40 questionnaire that was completed on or following study enrollment. The severity of pruritus was ranked according to itch domain score on the PBC-40:
- No itch: 0
- Itch of any severity: ≥1
- Mild itch: 1 to 6
- Clinically significant itch: ≥7
A total of 225 individuals completed the itch domain of the PBC-40 at or following baseline. Of these patients, 192 completed their survey on the date of enrollment and 33 completed the PBC-40 at a future date. The mean patient age at baseline was 55.4± 10.9 years. Overall, 97.8% (220 of 225) of the participants were female.
Results of the study showed that pruritus of any severity was self-reported by 88.9% (200 of 225) of participants. Among the patients, however, only 39.1% (88 of 225) of them had recent medical record–documented pruritus. Moreover, clinically significant pruritus was self-reported by 53.3% (120 of 225) of patients. Among these individuals, 53.3% (64 of 120) of them had recent medical record–documented pruritus.
Additionally, participants who reported clinically significant pruritus seemed to have higher mean scores across PBC-40 domains, which were indicative of decreased HRQoL, compared with individuals with no/mild patient-reported pruritus or medical record–documented pruritus.
“Research based only on medical records underestimates the true burden of pruritus, meaning physicians may be unaware of the extent and impact of pruritus, leading to potential undertreatment,” the authors concluded.
