Eligibility criteria

♦ List the eligibility criteria, ensuring that each one is relevant and necessary.

♦ Avoid arbitrary exclusion criteria such as upper and lower age limits.

♦ Include the requirements of informed consent.

♦ Include, where appropriate, completion of baseline patient-completed questionnaire^), e.g. quality oflife questionnaires.

♦ Definitions such as those of staging and performance status are best given in appendices.

Box 7.7 gives an example of the eligibility criteria from a randomized trial in the management of malignant pleural mesothelioma.

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