Patient reported outcomes (PROs) are measures of health that come directly from patients and have not been interpreted by an observer. They are playing an increasing role in the evaluation of healthcare as they often differ from the observations of others. They provide information about the patient’s experience of treatment that may not be recorded using only standard outcomes. For cancer patients the most common questionnaire is called the EORTC QLQ-C30. This can be supplemented by additional disease-specific modules to increase sensitivity and content validity.
Pelican has supported studies that develop and validate disease-specific modules for the EORTC QLQ-C30, more detail can be found below.
Validation of a disease-specific EORTC module for colorectal liver metastases
International clinical and psychometric validation of a PROM for colorectal liver metastases: the EORTC QLQ-LMC2.
A module for patients with colorectal liver metastases including 21 questions (addressing nutritional problems, fatigue, pain and emotional issues) has been developed. It is called the QLQ-LMC21.
This international study, including oncologists and statisticians from the UK, France, Germany and Norway, aimed to validate the module. 356 patients, either undergoing hepatectomy or primary palliative treatment, completed the QLQ-C30 and the QLQ-LMC21 before and three months after treatment.
The study found that the additional questionnaire was completed easily by patients and that it measured several aspects of health that were not covered in the original questionnaire. This resulted in the validation of the QLQ-LMC21.
Read the abstract from the British Journal of Surgery.
Validation of a disease-specific EORTC module for G.I.-related neuroendocrine tumours
Clinical and Psychometric Validation of a Disease-Specific Questionnaire Module in Assessing the Quality of Life of Patients with G.I.-related Neuroendocrine Tumours.
A module for patients with gastro-intestinal related neuroendocrine tumours (G.I. NETs) has been developed with 21 questions. It is called the QLQ-G.I.NET21.
This international study, including 10 UK and 9 international centres, aimed to carry out a phase 4 validation study to test the structure, validity and reliability of the QLQ-G.I.NET21. It also aimed to assess the quality of life of the patients using the QLQ-C30 and the QLQ-G.I.NET21 before and after treatment.
The module has been found to be a valid and responsive tool for assessing quality of life in gut, pancreas and liver neuroendocrine tumours.
Read the abstract from the British Journal of Cancer.
Development of a disease-specific EORTC module for cholangiocarcinoma and gall bladder cancer
Development of a questionnaire EORTC module to measure the Quality of Life in patients with Cholangiocarcinoma and Gall Bladder Cancer.
A module for patients with colorectal liver metastases has been developed, called the QLQ-LMC21. A module for patients with pancreatic cancer has also been developed, called the QLQ-PAN26.
This international study, including invesigators from the UK, Taiwan, Italy and Germany, aimed to test the questions and issues of the LMC21 and PAN26 in cholangiocarcinoma patients and assess whether either or both are adequate. If it was found that neither alone were adequate then the EORTC protocol would be used to develop a new module questionnaire for cholangiocarcinoma patients.
Following interviews with patients and healthcare professionals 5 questions from PAN26, 15 from LMC21 and 3 extra questions were used to create a 21 item module. This is the disease-specific module for patients with cholangiocarcinoma and gall bladder cancer.
Read the abstract from the British Journal of Cancer.