Development and Validation of the Simplified Chinese Version of EORTC QLQ-HCC18 for Patients with Hepatocellular Carcinoma

Yang, Zuozhang; Wan, Chonghua; Li, Wei; Cun, Yingli; Qian, Meng; Ding, Yuanlin; Chen, Pingyan

doi:10.3109/07357907.2015.1036280

Cited by 8 publications

(15 citation statements)

References 21 publications

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“…To our knowledge, the all-stage conceptual model developed in the current study is the first of its kind. Patients with BTC experience reduced HRQoL [19,36,37], and this was reflected in the current study. Patients with BTC mentioned 46 signs/symptoms and eight impacts of BTC that had not been identified from the targeted literature and clinician interviews, highlighting the importance of obtaining information on the patient experience directly from patients and suggesting a need to ensure fit-for-purpose patient-centred outcomes measurement in BTC clinical trials.…”

Section: Discussionsupporting

confidence: 62%

“…No recent BTC-related qualitative research studies were identified from the literature review. Six non-qualitative studies were identified (two retrospective cohort studies and four prospective studies) [14,[32][33][34][35][36], and 19 concepts related to signs/symptoms or impacts of BTC were extracted from these and included in the preliminary conceptual model. These studies used validated questionnaires to assess patients' HRQoL in the physical, mental and social domains in the context of BTC [14,[32][33][34][35][36].…”

Section: Targeted Literature Searchmentioning

confidence: 99%

“…Six non-qualitative studies were identified (two retrospective cohort studies and four prospective studies) [14,[32][33][34][35][36], and 19 concepts related to signs/symptoms or impacts of BTC were extracted from these and included in the preliminary conceptual model. These studies used validated questionnaires to assess patients' HRQoL in the physical, mental and social domains in the context of BTC [14,[32][33][34][35][36]. The preliminary conceptual model developed from the literature was used to help guide the qualitative interviews.…”

Section: Targeted Literature Searchmentioning

confidence: 99%

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Understanding Patient Experience in Biliary Tract Cancer: A Qualitative Patient Interview Study

Patel

Lie²,

Gwaltney³

et al. 2021

Oncol Ther

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Introduction: Patients living with biliary tract cancer (BTC) experience a decline in healthrelated quality of life (HRQoL). This study aimed to obtain a comprehensive understanding of the patient experience of BTCrelated signs/symptoms and the impacts of these on daily functioning and HRQoL. Methods: Patients with BTC participated in qualitative semi-structured concept elicitation interviews. Signs/symptoms and impacts of BTC were initially explored by targeted literature searches and interviews with five clinicians. Patient interviews were transcribed and coded using qualitative research software. Concept saturation was assessed over five interview waves. A sign/symptom or impact was defined

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Section: Discussionsupporting

confidence: 62%

Section: Targeted Literature Searchmentioning

confidence: 99%

Section: Targeted Literature Searchmentioning

confidence: 99%

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Understanding Patient Experience in Biliary Tract Cancer: A Qualitative Patient Interview Study

Patel

Lie²,

Gwaltney³

et al. 2021

Oncol Ther

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“…Finally, nine publications combined patient groups undergoing different treatment options (surgery/medical therapy/interventional treatment) for the reporting of HRQoL outcomes. In these cases, assignment of HRQoL outcomes to a specific treatment (surgery vs. medical therapy vs interventional treatment) was impossible [ 28 , 42 , 56 , 58 , 87 , 88 , 120 , 127 , 132 ]. In summary, only three studies remained for quantitative analyses (Fig.…”

Section: Resultsmentioning

confidence: 99%

Health-related quality of life in primary hepatic cancer: a systematic review assessing the methodological properties of instruments and a meta-analysis comparing treatment strategies

et al. 2021

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Purpose Patient-reported outcomes including health-related quality of life (HRQoL) are important oncological outcome measures. The validation of HRQoL instruments for patients with hepatocellular and cholangiocellular carcinoma is lacking. Furthermore, studies comparing different treatment options in respect to HRQoL are sparse. The objective of the systematic review and meta-analysis was, therefore, to identify all available HRQoL tools regarding primary liver cancer, to assess the methodological quality of these HRQoL instruments and to compare surgical, interventional and medical treatments with regard to HRQoL. Methods A systematic literature search was conducted in MEDLINE, the Cochrane library, PsycINFO, CINAHL and EMBASE. The methodological quality of all identified HRQoL instruments was performed according to the COnsensus-based Standards for the selection of health status Measurements INstruments (COSMIN) standard. Consequently, the quality of reporting of HRQoL data was assessed. Finally, wherever possible HRQoL data were extracted and quantitative analyses were performed. Results A total of 124 studies using 29 different HRQoL instruments were identified. After the methodological assessment, only 10 instruments fulfilled the psychometric criteria and could be included in subsequent analyses. However, quality of reporting of HRQoL data was insufficient, precluding meta-analyses for 9 instruments. Conclusion Using a standardized methodological assessment, specific HRQoL instruments are recommended for use in patients with hepatocellular and cholangiocellular carcinoma. HRQoL data of patients undergoing treatment of primary liver cancers are sparse and reporting falls short of published standards. Meaningful comparison of established treatment options with regard to HRQoL was impossible indicating the need for future research.

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“…Several different questionnaires have been employed to measure HRQoL in studies of HCC [7]; however, only the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18-question module (EORTC QLQ-HCC18) was developed speci cally to assess symptom burden and impact on HRQoL in people with HCC [12][13][14]. As it stands, there are limited published data demonstrating the measurement properties of the QLQ-HCC18 within an unresectable HCC population, as well as within speci c subpopulations including viral hepatitis comorbidities (comorbid HBV and HCV versus no comorbidity), line of therapy (second-versus third-line or greater), and geographic region (Asia versus Europe).…”

Section: Introductionmentioning

confidence: 99%

Psychometric Validation of the EORTC QLQ-HCC18 in Patients with Previously Treated Unresectable Hepatocellular Carcinoma

Serrano

Podger

Barnes

et al. 2021

Preprint

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Purpose: Demonstrate the measurement properties of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18-question module (EORTC QLQ-HCC18) within a previously treated, unresectable HCC clinical trial population that was distinct from the published QLQ-HCC18 validation population. Methods: Analyses were conducted using data from BGB-A317-208, an open label, international, clinical trial of the monoclonal antibody tislelizumab in adult HCC patients. The EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and QLQ-HCC18 were assessed at baseline as well as weeks 3 and 9. Psychometric validation of the QLQ-HCC18 included reliability, construct validity, ability to detect change, and meaningful within-patient change (MWPC). Known-groups validity and MWPC analyses were also stratified on several pre-defined subpopulations. Results: A total of 248 patients were included. The QLQ-HCC18 fatigue, nutrition, and index domains demonstrated acceptable internal consistency; acceptable test-retest reliability was found for fatigue, body image, nutrition, pain, sexual interest, and index domains. The QLQ-HCC18 fatigue domain achieved acceptable concurrent validity for 13 of 16 correlations; the index domain achieved acceptable concurrent validity for 15 of 16 correlations. Clear differentiation of the QLQ-HCC18 change scores between improvement and maintenance anchor groups were observed for body image, fatigue, pain, and index domains. Differentiation between deterioration and maintenance anchor groups were observed for fever and fatigue domains. MWPC point estimates defining improvement for the QLQ-HCC18 fatigue and index domains were -7.18 and -4.07, respectively; MWPC point estimates defining deterioration were 5.34 and 3.16, respectively. Conclusions: The EORTC QLQ-HCC18 fatigue and index domains consistently demonstrated robust psychometric properties, supporting the use of these domains as suitable patient-reported endpoints within a previously treated, unresectable HCC patient population.

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Development and Validation of the Simplified Chinese Version of EORTC QLQ-HCC18 for Patients with Hepatocellular Carcinoma

Cited by 8 publications

References 21 publications

Understanding Patient Experience in Biliary Tract Cancer: A Qualitative Patient Interview Study

Understanding Patient Experience in Biliary Tract Cancer: A Qualitative Patient Interview Study

Health-related quality of life in primary hepatic cancer: a systematic review assessing the methodological properties of instruments and a meta-analysis comparing treatment strategies

Psychometric Validation of the EORTC QLQ-HCC18 in Patients with Previously Treated Unresectable Hepatocellular Carcinoma

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