Types of questionnaire

Bjordal and Kaasa [55] compiled a list of criteria that shouldbe considered when choosing a QL instrument for use in a cancer trial. In addition to being cancer specific, completed by patients, brief, and easy to understand and respond to, it is important that it is multi-dimensional and covers physical, functional, psychological and social aspects.

Questionnaires that are now considered standard have undergone a number of rigorous evaluations, to show that they have validity, reliability and responsiveness [29].

♦ Validity means that the question measures what it is supposed to. There are a number of aspects of validity, namely content, criterion, construct, and discriminative validity.

♦ Content validity is an assessment of the relevance and validity of items, i.e. are the questions understood and not ambiguous?

♦ Criterion validity is the strength of the relationship between the new instrument and some other criterion measuring the same characteristic (ideally a gold standard).

♦ Construct validity is evidence that the instrument is broadly behaving as expected and shows similar (convergent validity) or opposite (divergent validity) relationship with other appropriate measures.

♦ Discriminative validity is the ability of the instrument to distinguish groups of people by their responses to the questionnaire and some other criteria (e.g. disease severity).

♦ Reliability is a measure of random error. It can be assessed by repeated applications of the same test (test-retest reliability) or by analysing the internal consistency of a scale. The latter involves measuring the relationship between a number of questions about the same aspects (i.e. multiple indicators for happiness).

♦ Responsiveness is the ability of the instrument to detect changes that occur as a result of an intervention. This means that there must be a range of responses to the question, and that not everyone will respond with either the top or bottom category (the so-called ceiling or floor effect).

Two types of questionnaires are likely to be used in cancer trials, those that are generic and those that are cancer-specific. For instance, in a situation such as testicular cancer where cure is common, the aim of QL assessment may be to judge whether the patient has returned to the same QL as the general population, and thus the use of a generic, rather than a cancer-specific, questionnaire might be appropriate. In other situations a cancer-specific questionnaire maybe more appropriate.

Generic questionnaires

Generic questionnaires concentrate on such areas as ability to perform daily activities, shopping, caring for oneself, etc. Widely used generic questionnaires include the Medical Outcomes Survey (MOS) Short form (SF36) [56], the Nottingham Health Profile (NHP)[57], the Sickness Impact Profile (SIP) [58] and the McMaster Health Index Questionnaire (MHIQ) [59,60].

The MOS SF36 asks thrity-six questions covering eight health concepts, and has been designed to be self-completed by the patient or administered by a trained interviewer in person or on the telephone.

The NHP is an instrument designed to measure subjective health status in six areas: physical mobility, pain, sleep, emotional reactions, social isolation, and energy. It is composed of a number of statements, which are answered 'yes' or 'no.' Scores in each section are summed and standardized to a 0-100 scale.

The SIP measures behavioural impact of sickness in terms of dysfunction. There are 136 items in twelve categories to which the respondent answers 'yes' or 'no.' It takes an average of 30 minutes to complete. Note that this measures negatives, not levels of positive functioning.

The MHIQ has three scales (physical, social and emotional) and fifty-nine items, some of which are used in more than one scale.

Cancer-specific questionnaires

Cancer-specific questionnaires focus on the symptoms and side effects of specific diseases and/or treatments. Widely used cancer-specific questionnaires include the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life thirty item core questionnaire (QLQ-C30) [61], the Functional Assessment of Cancer Treatment (FACT) [62], the Rotterdam Symptom Checklist (RSCL) [63], the Functional Living Index-Cancer (FLIC) [64] and the Cancer Rehabilitation Evaluation System (CARES) [65].

The EORTC Quality of Life core questionnaire (QLQ-C30) includes thirty questions covering five functional scales (physical, role, cognitive, emotional, and social) three symptom scales, a global QL scale, and a number of single items. Additional modules have been, or are being, developed for bladder, brain, breast, colorectal, gastric, head and neck, lung, oesophageal, ovarian, and pancreatic cancers, as well as leukaemia and myeloma, and to cover aspects such as palliative care, body image, high-dose chemotherapy, and neuropathy.

The FACT-G (FACT General) questionnaire consists of thirty-three core questions covering physical well-being, social/family well-being, relationship with medical staff, emotional well-being and fulfilment/contentment. It does not include symptoms, as these are contained in additional disease-specific questionnaires targeting different disease sites, for instance lung, head and neck, and genitourinary tract.

The RSCL concentrates on physical symptoms and psychological problems. A number of different versions are available, but the original contained thirty items each scored on a 4-point Likert scale, from 'not at all' to 'very much.' Two major subscales can be formed (an 8-item psychological scale, and an 18-item physical scale) but the questionnaire is perhaps lacking in other dimensions of QL - sexual functioning, self care, vocational and social functioning and satisfaction with medical care. However an 'activities of daily living' scale has been added.

The FLIC is a 22-item questionnaire developed to assess vocational, psychological, social and somatic areas of function. Each question takes the form of a visual analogue scale (VAS) and is scored as a whole number between 0 and 7.

The full CARES questionnaire contains 139 items of which the patient completes between ninety-one and 132 items, all scored on a 5-point scale (0-4). It includes global QL, five summary scores (physical, psychosocial, medical intervention, marital, and sexual) and thirty-one specific subscales. A short form version consists of fifty-nine items [66].

36 week

Mean Breast

Cancer Chemotherapy 8 Questionnaire score

36 week

Time (weeks)

Fig. 6.10 Mean Breast Cancer Chemotherapy Questionnaire (BCQ) score over time (adapted from Levine etal., [67]).

Other relevant questionnaires

A number of more specific questionnaires (not counting the specific modules developed as additions to the EORTC and FACT general questionnaires) have also been developed. For instance, Levine et al. [67] developed a questionnaire specifically to assess the outcome of patients with stage II breast cancer undergoing adjuvant chemotherapy. Their paper provides a good example of how questionnaires are developed and how the validity, reproducibility and responsiveness are tested, and Fig. 6.10 shows the responsiveness of their questionnaire to two durations of chemotherapy.

In addition, the Hospital Anxiety and Depression Scale (HADS) [68] has been used in a number of cancer clinical trials. This is because although many instruments have sections covering mental health, most will only detect a 'clinical case' of anxiety or depression and give no information about the nature of the psychiatric disorder. The HADS is a self-assessment mood scale specifically designed for non-psychiatric settings, and focuses on the two most common psychological aspects - anxiety and depression. Most importantly, cut-off points have been calculated for both of the 7-item 4-point scales so that patients can be classed as 'normal,' 'borderline' or 'case' anxiety or depression.

The EuroQol (EQ5D) [69], is a simple questionnaire with a choice of three responses to each of its five questions. It is widely used by health economists because from the responses to these five questions a single utility value can be generated.

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