Onkologie
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In discussing design and results of randomized clinical trials, in particular with clinical oncologists, one often encounters the opinion that a phase III trial is a complicated, highly costly, and difficult task. Part of this opinion seems to originate in myths around underlying biostatistical principles such as randomization, sampling and sample size, statistical hypotheses, statistical error probabilities, and statistical power. This work clarifies basic statistical issues of randomized clinical trials and the interpretation of their results. ⋯ They concern choice of study design, choice of participating centers, and recruitment of patients as well as statistical questions of establishing study hypotheses and interpreting p values. These myths are shown to be caused primarily through a misunderstanding of statistical inference and statistical thinking that can be avoided when a rational understanding of statistical principles is translated into a clinical research approach. We also conclude that before clinical evidence is summarized from different studies each study should be examined thoroughly.
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We wanted to understand coping strategies specific to different phases up to two years after radiotherapy, to identify patients who are at higher risk of mood disturbances and to characterise the association between coping strategies and psychosocial adaptation. ⋯ The correlation of coping mechanisms at the beginning of radiotherapy with low QoL and high psychosocial stress at 2 years could help to identify patients at risk for low psychosocial adaptation. Psycho-oncologically trained teams of physicians would best correspond to this profile of needs and would contribute significantly to an ameliorated adaptation of patients to cancer which could lead to higher life satisfaction.
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Editorial Comment
Statistical trial designs and clinical practice: are they compatible?