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  • 1
    ISSN: 1569-8041
    Keywords: clinical trials ; methodology ; ovarian cancer ; quality of life ; study design
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:The pattern of symptoms experienced by cancer patientsduring chemotherapy is very complex. Consequently, quality of life (QOL)assessment has to be carefully planned to capture clinically relevant changes. Patients and methods:A clinical model of changes in symptomsexperienced by symptomatic metastatic patients during several courses ofchemotherapy has been developed. The model differentiates cancer-relatedsymptoms, acute side-effects, chronic side-effects and symptoms not relatedto cancer. The model was used to predict changes in each of these four symptomgroups. Three time points were selected (post-cycle 2, pre-cycle 3, post-cycle5) and an appropriate window around each time point was set. The modelpredictions were tested empirically with 56 patients with advanced ovariancancer who completed the EORTC QLQ-C30 plus disease specific items during asix-cycle course of chemotherapy. Results:The changes observed in the sample were in accordancewith the changes predicted by the clinical model. Results from patients whodid not complete the questionnaire within the specified time windows tendedto dilute the findings from the group who did. Conclusions:A clinical model is useful in the planning of QOLassessments in order to capture clinically relevant effects. Such models alsofacilitate the interpretation of QOL studies, particularly when cyclicshort-term effects and chronic side-effects are overlaid on disease symptoms,as is the case with chemotherapy for cancer.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1573-2649
    Keywords: Attrition ; compliance ; lung cancer ; missing values ; psychological data ; quality of life ; randomised trials
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Standardization in the choice of quality of life (QOL) instruments and their application in randomised clinical trials have been advocated and generally accepted. However, there is now an urgent need to address the problems relating to the analysis and presentation of the data thus generated. There are intrinsic difficulties associated with QOL data, namely its multidimensional nature, attrition and missing data, and there is no consensus as to how these problems should be dealt with. This paper therefore considers there problems using interim data from a large Medical Research Council randomised trial in patients with small cell lung cancer and a poor prognosis, in which attrition and compliance are major concerns. Three possible approaches to the analysis of these data, which use different subsets of patients, are examined in detail. The strengths and weaknesses of these three methods are discussed, and examples of their use in the literature are given and compared with other reported approaches. The need for a standard definition of compliance is also emphasised, and a method of presentation suggested. The best current advice is that QOL data should be analysed in a number of different ways, and conclusions reached only when consistency is seen.
    Type of Medium: Electronic Resource
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  • 3
    Electronic Resource
    Electronic Resource
    Springer
    Quality of life research 5 (1996), S. 496-502 
    ISSN: 1573-2649
    Keywords: Clinical trials ; guidelines ; health-related quality of life ; quality of life ; reporting
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Clinical trials involving quality of life measurement published in the literature suffer from important weaknesses due to the lack of information on numerous topics. The psychometric properties of the instruments are often lacking as well as data on the number of patients treated and analyzed. The handling of missing data is rarely documented. In order to facilitate the reporting of trials and the evaluation of published results, this article proposes a set of general guidelines for the reporting of clinical trials which include a quality of life assessment. A checklist designed to assist authors is appended.
    Type of Medium: Electronic Resource
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  • 4
    Electronic Resource
    Electronic Resource
    Springer
    Quality of life research 6 (1997), S. 0-0 
    ISSN: 1573-2649
    Keywords: Anticipated effect size ; ; Hospital Anxiety and Depression Scale (HADS) ; quality of life ; randomized trials ; sample size ; small cell lung cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract This paper describes the methods appropriate for calculating sample sizes for clinical trials assessing quality of life (QOL). An example from a randomized trial of patients with small cell lung cancer completing the Hospital Anxiety and Depression Scale (HADS) is used for illustration. Sample size estimates calculated assuming that the data are either of the Normal form or binary are compared to estimates derived using an ordered categorical approach. In our example, since the data are very skewed, the Normal and binary approaches are shown to be unsatisfactory: binary methods may lead to substantial over estimates of sample size and Normal methods take no account of the asymmetric nature of the distribution. When summarizing normative data for QOL scores the frequency distributions should always be given so that one can assess if non-parametric methods should be used for sample size calculations and analysis. Further work is needed to discover what changes in QOL scores represent clinical importance for health technology interventions.
    Type of Medium: Electronic Resource
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