How to Test QoL

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In the recent past, there was diffuse scepticism among researchers on using QoL tests in their trials or a trend towards using non-standardised questionnaires [14]. The former is due to the high number of methods for testing QoL: by interviews (structured, semi-structured, non-structured), by questionnaires (standardised, non-standardised) and by ad hoc questions. Theoretically speaking, most of them can be easily and efficiently used in clinical practice but as already explained, cannot be comparable and useful in a clinical research setting. In fact, the ideal instrument for achieving this target should have the following characteristics: able to analyse the four "important" domains, standardised, validated, easy to be completed and cross-cultural.

During the last 15 years, different kinds of questionnaires have been developed. They range from generic instruments, designed to test QoL in almost all kinds of patients, to specific for a particular kind of cancer. In the following, we briefly summarise these tests.

The SF-36 [15] and the EuroQoL instruments [16] represent generic health state index. They are well validated and are useful especially in testing QoL in chronically ill patients. They do not take into account specific problems for cancer patients and symptoms correlated to therapy.

The next reasonable step was to develop cancer-specific QoL questionnaires. So far, the most used cancer-specific questionnaires have been: the Rotterdam Symptoms Checklist (RSCL) [17], the Cancer Rehabilitation Evaluation System Short Form (CARES-SF) [18], the Functional Living Index-Cancer (FLIC) [19] and the European Organization for Research and Quality of Life Core 30 Questionnaire (EORTC QLC-C30) [20, 21].

The latter is, so far, the most widely used and validated questionnaire. The first studies started in 1986 and the final version was published in 1993. It is a multidimensional questionnaire, self-administrated and available in different languages. It contains 30 items that explore various aspect of QoL. In the fist part, the QLC-C30 explores "generic" and various aspects of QoL by five functional scales (role, emotional, physical, cognitive and social) and 3 symptom scales (fatigue, pain nausea and vomiting). In the second part, the influence of cancer-specific manifestations (such as sleep disturbance, financial impact of the disease, appetite loss) is analysed. The third part summarises the global results by two items on global health and QoL on a 7-point Likert scale.

The unique feature of this test is that it represents a "core instrument" for oncologic trials as it allows collection of a broad spectrum of information on all kinds of cancer patients. In fact, during the following years, the European Organization for Research and Treatment of Cancer developed detailed guidelines for creation of a new supplemental questionnaire [22, 23] to study the effect of particular types of cancer on QoL. Modules related to brain cancer [24], breast cancer [25] and lung cancer [26] were set up. In 1999, Sprangers et al. [27] published the Colorectal Cancer-specific Quality of Life Questionnaire Module (QLQ-CR38). It is structured as 38 items, employing the four category response options as the core instrument (QLC-C30). Nineteen questions are completed by all patients and they test function (body imagine, sexual functioning) and symptoms (micturition and gastrointestinal problems, chemotherapy side effects and weight loss). The other 19 are completed only by a subgroup and check sexual problems in male or female, defecation (only in patients with intact sphincter) or stoma-related problems (only in patients with stoma). In this way, the QLQ-CR38 explores symptoms and side effects of all different treatments for colorectal cancer (surgery with or without a temporary/permanent stoma, radio-and/or chemotherapy), becoming a tailored questionnaire for all rectal cancer patients.

In our experience, as in the literature, the QLQ-CR38 plus QLC-C30 can be easily completed by most of the patients without assistance, even if they have a low education level or old age. The average time to complete both tests is 12 minutes.

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