Thresholds for clinical importance for four key domains of the EORTC QLQ-C30: physical functioning, emotional functioning, fatigue and pain.

BACKGROUND: The EORTC QLQ-C30 is one of the most widely used quality of life questionnaires in cancer research. Availability of thresholds for clinical importance for the individual questionnaire domains could help to increase its interpretability. The aim of our study was to identify thresholds for clinical importance for four EORTC QLQ-C30 scales: Physical Functioning (PF), Emotional Functioning (EF), Pain (PA) and Fatigue (FA). METHODS: We recruited adult cancer patients from Austria, the Netherlands, Poland and the UK. No restrictions were placed on diagnosis or type or stage of treatment. Patients completed the QLQ-C30 and three anchor items reflecting potential attributes of clinically important levels of PF, EF, PA and FA. We merged the anchor items assessing perceived burden, limitations in daily activities and need for help into a dichotomous external criterion to estimate thresholds for clinical importance using Receiver Operator Characteristic (ROC) analysis. RESULTS: In our sample of 548 cancer patients (mean age 60.6 years; 54 % female), the QLQ-C30 scales showed high diagnostic accuracy in identifying patients reporting burden, limitations and/or need for help related to PF, EF, PA and FA. All areas under the curve were above 0.86. CONCLUSIONS: We were able to estimate thresholds for clinical importance for four QLQ-C30 scales. When used in daily clinical practice, these thresholds can help to identify patients with clinically important problems requiring further exploration and possibly intervention by health care professionals.

Development of a quality of life questionnaire for patients with pancreatic neuroendocrine tumours (the PANNET module).

Pancreatic neuroendocrine tumours (panNET) are heterogeneous neoplasms usually characterised by slow growth and secretion of hormones, which often cause symptoms. The effect of these symptoms on quality of life (QoL) has not previously been examined in detail. EORTC (European Organisation for Research and Treatment of Cancer) guidelines were followed in phases 1-3 to produce a potential module of questions usable for trials in panNET, focusing on three common types of panNET. For two less common types, a list of symptoms was constructed. Following an extensive literature search and phase 1a interviews with patients and healthcare workers, a long list of potential issues (169) was obtained. This list was shown to 12 patients from three countries in phase 1b interviews to check that no items were missed. The list was reduced to 57 issues. The list of issues was converted to questions, mainly from existing validated questions within the EORTC item library. The list of questions was then used in a phase 3 international study in eight countries using seven languages. A provisional module of 24 items is presented for use in nonfunctioning panNET, gastrinoma and insulinoma. This module increases knowledge concerning QoL in this condition and may be a useful adjunct in clinical trials. A phase 4 trial is being considered for validation of this questionnaire.

Patient-reported outcomes after hepatic resection of colorectal cancer metastases.

PURPOSE: Hepatic resection of colorectal carcinoma (CRC) liver metastases is increasing, but evidence for the impact of surgery on patient-reported outcomes (PROs) is limited. This study aimed to describe comprehensively the impact of liver surgery for CRC hepatic metastases on PROs. PATIENTS AND METHODS: Consecutive patients selected for hepatic resection completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and Quality of Life Questionnaire-Liver Metastases C21 before and 3, 6, and 12 months after surgery. For functional scales, mean scores with 95% CIs were calculated at each time point, with differences in scores of at least 10 points considered clinically significant. Responses to symptom scales and items were categorized as minimal or severe. Proportions and 95% CIs for each symptom category were calculated. RESULTS: Hepatic surgery was planned in 241 patients but abandoned in nine because of unresectable disease. There were two postoperative deaths, 58 complications (25.2%), and 32 patients (14.9%) with disease recurrence. Questionnaire compliance was excellent (> 95% at all time points). After surgery, most functional aspects of health decreased, and the proportions of patients with severe symptoms increased; role function deteriorated significantly, and 30% of patients reported severe activity/vigor problems. Functional scales recovered by 6 months and were maintained at 1 year. Postoperative symptoms returned to baseline levels at 12 months, but 32.1% of patients reported severe problems with sexual dysfunction and 11.9% with abdominal pain. CONCLUSION: These findings provide new evidence regarding outcomes of liver resection for CRC metastases. It is recommended that patients be reassured that surgery has a minimal and short-lived detrimental impact on health.