Validation of the EORTC QLQ-GINET21 questionnaire for assessing quality of life of patients with gastrointestinal neuroendocrine tumours

Abstract

Background:Quality of life is an important end point in clinical trials, yet there are few quality of life questionnaires for neuroendocrine tumours.Methods:This international multicentre validation study assesses the QLQ-GINET21 Quality of Life Questionnaire in 253 patients with gastrointestinal neuroendocrine tumours. All patients were requested to complete two quality of life questionnaires – the EORTC Core Quality of Life questionnaire (QLQ-C30) and the QLQ-GINET21 – at baseline, and at 3 and 6 months post-baseline; the psychometric properties of the questionnaire were then analysed.Results:Analysis of QLQ-GINET21 scales confirmed appropriate aggregation of the items, except for treatment-related symptoms, where weight gain showed low correlation with other questions in the scale; weight gain was therefore analysed as a single item. Internal consistency of scales using Cronbach's α coefficient was >0.7 for all parts of the QLQ-GINET21 at 6 months. Intraclass correlation was >0.85 for all scales. Discriminant validity was confirmed, with values <0.70 for all scales compared with each other.Scores changed in accordance with alterations in performance status and in response to expected clinical changes after therapies. Mean scores were similar for pancreatic and other tumours.Conclusion:The QLQ-GINET21 is a valid and responsive tool for assessing quality of life in the gut, pancreas and liver neuroendocrine tumours.

Evaluating digestive neuroendocrine tumor progression and therapeutic responses in the era of targeted therapies: state of the art

“…The QLQ-C30 questionnaire has not been validated as a surrogate marker of tumor progression (Raymond et al 2011). QLQ-GINET21 includes items specific to NET patients and has been recently shown to change in response to expected clinical evolution after therapy (Davies et al 2006, Yadegarfar et al 2013. Thus, correlation between variation of the standardized qualityof-life assessment and tumor evolution should be examined for NET patients.…”

Ocena bezpieczeństwa i efektywność jabłczanu sunitynibu w przerzutowych guzach neuroendokrynnych trzustki (NEN G1/G2) w zależności od liczby i rodzaju wcześniejszych linii terapeutycznych — doniesienie wstępne

“…infiltration of vessels and nerve plexuses, location of the tumour in the head of the pancreas). Simultaneous administration of SSA with tyrosine multikinase inhibitor did not affect the exacerbation of the treatment tolerance, its effects or the deterioration in quality of life [17,24]. This observation is important from the clinical point of view, particularly in the light of the recent findings of the CLARINET study that confirm the antiproliferation action of lanreotide in PNENs [6].…”

Psychometric development of the Gastrointestinal Symptom Rating Questionnaire (GSRQ) demonstrated good validity

“…Research and Treatment of Cancer (EORTC) Quality of Life Group (http://groups.eortc.be/qol/) has recently developed quality of life questionnaires for patients with cancer, with modular ''add-ons'' for GI disorders, such as the EORTC QLC-GINET21 [18]. These may have been a useful starting point for our instrument development; however, they were not available when we undertook the study.…”

“…Disease-specific instruments have been developed for inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), dyspepsia, gastroesophageal reflux disease (GORD), liver disease, and GI malignancy [17,18]. There are, however, many disorders for which no valid instruments exist.…”