Health-related quality of life questionnaires used in primary biliary cholangitis: a systematic review
Xin Ai1, Xian Yang1, Jia-min Xu1, Wen-xia Yang1, Ying-mei Tang2*
1The Second Affiliated Hospital of Kunming Medical University;2Department of Gastroenterology, The Second Affiliated Hospital of Kunming Medical University,Yunnan Research Center for Liver Diseases;
Abstract
Objective The purpose of this systematic review was to assess the suitability of HRQOL questionnaires in patients with primary biliary cholangitis.
Methods Five electronic databases were searched. The validity of translated questionnaires, floor and ceiling effects, internal consistency and test-retest reliability were investigated.
Results Forty-four studies were included, of which fifteen HRQOL questionnaires were identified. The instruments used most frequently were the PBC-40 (n = 22), followed by the SF-36 (n = 19), PBC-27(n=4), CLDQ (n = 3) and NIDDK-QA(n=2), the remaining instruments were uesd only once. Tweenty-six studies used a translated HRQOL questionnaire and only six reported or referenced a validation of the translated questionnaire.
Conclusions PBC-specific HRQOL questionnaires used in primary biliary cholangitis have generally good psychometric properties. But lots of studies directly applied the HRQOL tools without verifying the HRQOL tools validity and reliability in PBC patients. Thus, it is better for clinicians and researchers to test the measurement properties of HRQOL questionnaires before use it.
Key words: review, primary biliary cholangitis, health-related quality of life
*Corresponding author: Ying-mei Tang
mail address: tangyingmei_med@kmmu.edu.cn
Review criteria:
Inclusion criteria
1. Original studies of adult patients (≥18 years old) with primary biliary cholangitis, studies reporting generic or disease-specific HRQOL questionnaires as outcome measure.
2. The study had to be a randomized controlled trial, cohort study, case control study, clinical trial, or validation study of HRQL instruments.
Message for the clinic:
PBC-specific HRQOL questionnaires used in primary biliary cholangitis have generally good psychometric properties. It is better for clinicians and researchers to test the measurement properties of HRQOL questionnaires before use it.
1.Introduction
Primary biliary cholangitis(PBC) is an autoimmune disease, which characterized by interlobular cholangitis with progressive destruction, cholestasis, fibrosis and may develop into end-stage liver disease eventually[1, 2]. High-titer specific anti-mitochondrial antibodies and anti-nuclear antibodies GP120 and SP100 appeared in serum of PBC patients, and the level of IgM in peripheral blood also increased correspondingly[3]. Fatigue and pruritus are the most common symptoms of primary biliary cirrhosis, which affects patients’ quality of life seriously. Ursodeoxycholic acid(UDCA) is the first valid drug in the treatment of PBC, but 30% of patients with PBC do not have a biochemical response to UDCA[4, 5].The World Health Organization (WHO) defines quality of life as individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns[6]. And health-related quality of life (HRQOL) is defined as the influence of health and disease on quality of life[7]. Health-related quality of life (HRQOL) measures in chronic disease management is necessary as it assesses the overall impact on health from the patient’s perspective. A range of different questionnaires are used to evaluate HRQOL in PBC, including disease-specific and generic questionnaires, but no guidance of HRQOL questionnaires properties for clinicians and researchers to choose. The aim of this review was to evaluate the suitability of questionnaires used to assess HRQOL in primary biliary cholangitis.
2.Materials and methods
We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses
(PRISMA) statement guidelines for systematic reviews[8] to ensure a complete reporting in the development of the study protocol. This systematic review was performed in January 2020.
2.1 Data sources
We performed electronic searches in the following five databases: PubMed, the Cochrane Library, Web of Science, Wan Fang Database, and Chinese National Knowledge Infrastructure. The search was run on 17 January 2020.
2.2 Search strategy
The search strategy included a combination of the following relevant keywords: “health-related quality of life”, “quality of life”, “primary biliary cholangitis” and “primary biliary cirrhosis”. Electronic database searches were limited to English-language publications.
2.3 Inclusion and exclusion criteria