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Objectives-To study whether linguistic analysis and changes in information leaflets can improve readability and understanding. Design-Randomised, controlled study. Two information leaflets concerned with trials of drugs for conditionsldiseases which are commonly known were modified, and the original was tested against the revised version. Setting-Denmark. Participants-235 persons in the relevant age groups. Main measures-Readability and understanding of contents. Results-Both readability and understanding of contents was improved: readability with regard to both information leaflets and understanding with regard to one of the leaflets. Conclusion-The results show that both readability and understanding can be improved by increased attention to the linguistic features of the information.

It is a central principle in medical ethics that vulnerable patients are entitled to a degree of protection that reflects their vulnerability. In critical care research, this protection is often established by means of so-called proxy consent. Proxy consent for research participation constitutes a substituted judgement by a close relative or friend, based on knowledge of patient's values, preferences, and view of life. For the consent to be genuine, the proxy must be informed of and understand three fundamental aspects of research practice: (1) that participation is voluntary and the consent can be withdrawn at any time; (2) that the research is designed to benefit future patients and society as a whole, and not the individual study participant; and (3) that participation involves an incremental non-therapeutic risk. If this is not fulfilled because the research is to be conducted under circumstances where the proxy is unavailable, adequate protection of the patient must be ensured by other means. Thus, the research must be designed specifically to benefit critically ill patients, and the incremental non-therapeutic risk must only comprise a minimal risk.

Cancer patients demand a high level of involvement in decisions concerning treatment. Many patients are informed about experimental trials, and especially the first consultation may be crucial for the future communication and treatment process. Patients with nonresectable non-small-cell lung cancer or colorectal cancer informed about experimental chemotherapy completed a questionnaire on satisfaction with the communication process, general attitude towards experimental treatments, the substance of information, and personal contact with the physician following their first consultation in a medical oncology unit. Physicians completed a questionnaire on their perception of the patients' satisfaction. Among 68 physician -cancer patient pairs, 29 patients were informed on chemotherapy in randomised trials and 39 in nonrandomised studies. The general attitude towards experimental treatment was positive or very positive in 71% of patients. Information on the treatment was perceived as completely adequate in 93% of patients informed on randomised and in 67% informed on nonrandomised trials. Physicians underestimated the patients' satisfaction with the overall communication process, the personal contact, the patients' perceived sufficiency of the specific treatment information and their ability to decide on study entry. In conclusion, considerable differences were observed between patients informed about experimental chemotherapy in randomised and nonrandomised trials, both with respect to their perception of how adequate the information on the specific treatments were, and whether it was sufficient for decisions on study entry. This study type effect should be accounted for in future evaluations of communication and patient satisfaction. The data also support the fact that cancer patients have a desire for and ability to understand rather detailed and comprehensive treatment information.