A short version of a HRQoL questionnaire for Italian and Japanese patients with Primary Biliary Cirrhosis

Montali, Lorenzo; Tanaka, Atsushi; Riva, Paolo; Takahashi, Hiroki; Cocchi, C.; Ueno, Yoshiyuki; Miglioretti, Massimo; Takikawa, Hajime; Vecchio, Luca; Frigerio, Alessandra; Bianchi, Ilaria; Jorgensen, Roberta A.; Lindor, Keith D.; Podda, Mauro; Invernizzi, Pietro

doi:10.1016/j.dld.2010.01.004

Cited by 29 publications

(44 citation statements)

References 22 publications

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“…However, the domain “Symptoms” was found to have a Cronbach’s α coefficient of 0.52, indicating an unsatisfactory level of internal reliability. This result is similar to that of other validations in Italian, Japanese and Polish samples [12, 13]. This domain includes items 1 through 7 and is a heterogeneous domain; items 1–3 address food and alcohol intake, and items 4–7 investigate general discomfort along with eye and mouth dryness.…”

Section: Discussionsupporting

confidence: 88%

“…Our study sample had similar demographic and clinical characteristics to other PBC cohorts [12, 13], with the exception that only 20% of our cohort had biopsy proven cirrhosis (histological stage 4), less than the number seen in a recent Polish cohort [13]. …”

Section: Discussionmentioning

confidence: 68%

“…The PBC-27 is a shorter instrument derived from the PBC-40, created in 2010 by Montali et al [12]. Unlike the PBC-40, this scale consists of 27 items divided into seven domains: Symptoms (3 items), Dryness (2 items), Itch (3 items), Fatigue (8 items), Cognitive (5 items), Emotional (3 items) and Social (3 items) [12].…”

Section: Methodsmentioning

confidence: 99%

“…Unlike the PBC-40, this scale consists of 27 items divided into seven domains: Symptoms (3 items), Dryness (2 items), Itch (3 items), Fatigue (8 items), Cognitive (5 items), Emotional (3 items) and Social (3 items) [12]. The scoring system is the same as for the PBC-40.…”

Section: Methodsmentioning

confidence: 99%

“…To meet this necessity, Jacoby et al [11], created the first disease specific quality of life scale for PBC, the PBC-40, which was evaluated and found to have appropriate validity and reliability. The PBC-40 has since been cross-culturally adapted and validated into different languages [12, 13]; alongside the creation of the shorter PBC-27 [12]. …”

Section: Introductionmentioning

confidence: 99%

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Translation and validation of the Serbian primary biliary cholangitis-40 questionnaire

Zec

Popović

Matovic³

et al. 2017

PLoS ONE

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Background and aimsTo translate into Serbian and validate the Primary Biliary Cholangitis–40 (PBC-40) and PBC-27 questionnaires.Materials and methodsNinety-four consecutive outpatients with the diagnosis of PBC from three departments across two tertiary care institutions in Belgrade were enrolled from February to October 2016. Standard methodology for cultural adaption of healthcare related quality of life questionnaires was used, and included: a forward translation, backward translation and a pilot test of the Serbian PBC-40 on five patients who gave suggestions and comments. For evaluation of the questionnaires, acceptance was shown by the proportion of missing items and the internal consistency was assessed using Cronbach’s α coefficient. The PBC-40 was self-administered under the supervision of an experienced hepatologist. The PBC-27 is a shorter version of the PBC-40.ResultsA total of 92 (97.9%) of the patients were females. The mean age was 59.26 ± 1.05 years and the average length of disease was 60.45 ± 48.314 months. The average PBC-40 score was 85.62 ± 30.46. The total time needed to complete the questionnaire ranged from 7 to 16 minutes. The proportion of missing items was 5.45% (205/3760). Cronbach’s α for the entire scale was 0.93. Reliability for all of the domains of the PBC-40 was above 0.70, except for the domain “Symptoms” (α = 0.52). Overall reliability of the PBC-27 was α = 0.90. Domains “Dryness”, “Symptoms” and “Fatigue” demonstrated reliability below α = 0.70.ConclusionsThe Serbian PBC-40 is a valid and reasonably adequate for use in Serbian PBC patients. The PBC-40 is preferred over the PBC-27.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 68%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Translation and validation of the Serbian primary biliary cholangitis-40 questionnaire

Zec

Popović

Matovic³

et al. 2017

PLoS ONE

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A Systematic Review of Patient‐Reported Outcomes in Primary Biliary Cholangitis and Primary Sclerosing Cholangitis

et al. 2020

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Primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC) are associated with decreased health-related quality of life and debilitating symptoms. These experiences can be defined as patient-reported outcome (PRO) concepts and measured using PRO instruments. We identified all PRO concepts and instruments used in the PBC and PSC literature. This systematic review identified PBC and/or PSC studies from January 1, 1990, to May 6, 2019, that measured at least one PRO concept. Study population, design, PRO concept, PRO instrument, and validation data for PRO instruments were investigated. We provided descriptive statistics of PRO concepts and instruments used, stratified by population type. Use of PRO concepts and instruments were assessed over time. The search yielded 318 articles (69% in PBC, 18% in PSC, 13% in both, and 24% in drug trials). Forty-nine unique PRO concepts were identified. The five most common PRO concepts included pruritus (25%), fatigue (19%), broad health-related quality of life (16%), gastrointestinal adverse events (6%), and physical adverse events (6%). Only 60% of PRO concepts were measured with a PRO instrument, most of which were nonvalidated visual analogue or numeric rating scales. Only three of 83 PRO instruments were developed with feedback from the target populations (one for PBC, one for PSC, and one for both), and only six documented any psychometric testing in the target populations. Use of PRO instruments increased over time from 30% in the 1990s to 67% by 2019. Conclusion: The overwhelming majority of PRO instruments used in PBC/PSC were nonspecific and lacked patient validation or empirical justification. Significant opportunities exist to use qualitative methods to better understand patient experiences, and translate this knowledge into meaningful, patient-driven study outcomes. (Hepatology Communications 2020;4:1502-1515). P rimary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC) are chronic cholestatic liver diseases associated with significant morbidity, including decreased quality of life, (1-6) pruritus, (7-9) and fatigue, (10-14) among other symptoms. The primary outcomes of most clinical trials include disease endpoints or surrogates (e.g., alkaline phosphatase), rather than patient-reported outcomes (PROs), which capture how patients feel or function. PROs reflect a patient's health status, as it comes directly from the patient, without interpretation by anyone else including the clinician. (15) Patient experiences and perceptions are best evaluated using validated PRO instruments that were developed with Abbreviations: FDA, Food and Drug Administration; HRQOL, health-related quality of life; NOS, not otherwise specified; PBC, primary biliary cholangitis; PRO, patient-reported outcome; PSC, primary sclerosing cholangitis.

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Quality of life is significantly impaired in long-term survivors of acute liver failure and particularly in acetaminophen-overdose patients

et al. 2013

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Functional outcomes in long-term survivors of acute liver failure (ALF) are not well-characterized. The aim of this prospective study was to determine health related quality of life (HRQOL) in long-term adult ALF survivors. ALFSG registry participants completed the CDC HRQOL-14 and SF-36 questionnaires at a 1 and/or 2 year follow-up study visit. Responses were compared among ALF subgroups and to available U.S. general population controls. Among the 282 adult ALF patients, 125 had undergone liver transplantation (LT) while 157 were spontaneous survivors (SS), including 95 acetaminophen overdose (APAP) patients and 62 non-APAP SS. Acetaminophen SS patients reported significantly lower general health scores and more days of impaired mental and physical health, activity limitations due to poor health, pain, depression, and anxiety compared to the other groups (p < 0.001). There were no significant differences in coma grade, use of mechanical ventilation or ICP monitoring among the patient groups during their ALF hospitalization but the APAP SS had a significantly higher rate of psychiatric disease and substance abuse (p< 0.001). Compared to the U.S. general population, a greater proportion of the combined SS patients reported fair/poor health and >14 days of impaired physical/mental health and activity limitations due to poor health. In addition, a greater proportion of LT recipents reported >14 days of impaired physical/mental health. Similar results were observed using the SF-36 across the three ALF subgroups and compared to population controls. In conclusion, long-term adult ALF survivors report significantly lower quality of life scores compared to U.S. population controls. Furthermore, APAP SS patients report the lowest quality of life scores, possibly due to a higher rate of pre-morbid psychiatric and substance abuse disorders.

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A short version of a HRQoL questionnaire for Italian and Japanese patients with Primary Biliary Cirrhosis

Cited by 29 publications

References 22 publications

Translation and validation of the Serbian primary biliary cholangitis-40 questionnaire

Translation and validation of the Serbian primary biliary cholangitis-40 questionnaire

A Systematic Review of Patient‐Reported Outcomes in Primary Biliary Cholangitis and Primary Sclerosing Cholangitis

Quality of life is significantly impaired in long-term survivors of acute liver failure and particularly in acetaminophen-overdose patients

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