Pruritus in primary biliary cholangitis is under-recorded in patient medical records

Abstract

Objective: Cholestatic pruritus in primary biliary cholangitis (PBC) reduces patients' health-related quality of life (HRQoL). Despite this, existing research suggests that pruritus is under-recorded in patients' health records. This study assessed the extent to which pruritus was recorded in medical records of patients with PBC as compared with patient-reported pruritus, and whether patients reporting mild itch were less likely to have pruritus recorded. We also evaluated clinico-demographic characteristics and HRQoL of patients with medical record-documented and patient-reported pruritus.

Design: This cross-sectional study used clinical information abstracted from medical records, together with patient-reported (PBC-40) data from patients with PBC in the USA enrolled in the PicnicHealth cohort. Medical record-documented pruritus was classified as 'recent' (at, or within 12 months prior to, enrolment) or 'ever' (at, or any point prior to, enrolment). Patient-reported pruritus (4-week recall) was assessed using the first PBC-40 questionnaire completed on/after enrolment; pruritus severity was classified by itch domain score (any severity: ≥1; clinically significant itch: ≥7). Patient clinico-demographic characteristics and PBC-40 domain scores were described in patients with medical record-documented and patient-reported pruritus; overlap between groups was evaluated. Descriptive statistics were reported.

Results: Pruritus of any severity was self-reported by 200/225 (88.9%) patients enrolled; however, only 88/225 (39.1%) had recent medical record-documented pruritus. Clinically significant pruritus was self-reported by 120/225 (53.3%) patients; of these, 64/120 (53.3%) had recent medical record-documented pruritus. Patients reporting clinically significant pruritus appeared to have higher mean scores across PBC-40 domains (indicating reduced HRQoL), versus patients with no/mild patient-reported pruritus or medical-record documented pruritus.

Conclusion: Compared with patient-reported measures, pruritus in PBC is under-recorded in medical records and is associated with lower HRQoL. 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.

Keywords: CHOLESTASIS; CHOLESTATIC LIVER DISEASES; EPIDEMIOLOGY; HEPATOBILIARY DISEASE; QUALITY OF LIFE.

Figure 1

Study overview. *Baseline was defined as cohort enrolment. ^†On or within 12 months prior to baseline. ALP, alkaline phosphatase; HRQoL, health-related quality of life; PBC, primary biliary cholangitis.

Figure 2

Percentage of patients with no, mild or clinically significant patient-reported itch* according to whether or not they had recent^† pruritus documented in their medical record. *No patient-reported pruritus defined as PBC-40 itch domain score 0; mild, defined as score 1–6; clinically significant defined as score ≥7. ^†Recorded on or within the 12-month period prior to baseline. PBC, primary biliary cholangitis.

Figure 3

Median (IQR) PBC-40 domain scores on or after baseline* for the analysis cohort. Higher domain scores indicate poorer HRQoL. The black/white horizontal lines indicate the median values. The boxes represent the IQR (Q1–Q3). The error bars represent the recorded ranges for each domain. The minimum and maximum possible scores differ across domains (fatigue: 11–55, cognitive: 6–30, symptoms: 6–35, social: 8–50, itch: 3–15 and emotional: 3–15). Patients were required to complete the itch domain of the PBC-40 for inclusion in the analysis; however, patients may have omitted some or all questions in another domain of the survey. Therefore, patient numbers do not reflect the whole cohort in certain domains. *Baseline was defined as cohort enrolment. HRQoL, health-related quality of life; PBC, primary biliary cholangitis.