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 conditions/diseases 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. (shrink)

ABSTRACT Objectives: the purpose of this study is to explore laypersons’ attitudes towards and experiences of medical research, and to compare them with those of physicians in Japan. Designs and Participants: fourteen Japanese adults from the general public and seven physicians participated in one of three focus interviews. Setting: Osaka, Japan. Results: trust and distrust in the physician by whom the participants were invited to participate in research played a considerable role in their decisions about participation. That the participants felt (...) an obligation to participate was also expressed. The lay participants perceived medical research as something entirely outside of their world. A greater willingness to volunteer for research was expressed if there were direct benefits to themselves or their families. Research methods such as use of placebos, double blinds, and randomisations seemed to cause negative attitudes to medical research. All physicians were convinced of the need for medical research, including double‐blinded randomised control trials, and its significant role in medical progress. Most physicians thought that the greater awareness of the need for medical research in the community and a better understanding of the psychology of potential research participants were necessary and urgent. Conclusions: there is a good possibility that the lay public and medical professionals have sharply different beliefs about and attitudes towards every aspect of medical research. Building up a better and equal patient‐doctor relationship based on trust is a key issue in medical research, and it is mandatory to fill the gap in perception regarding medical research between them through fully informed debates. (shrink)

A patient's informed consent is required by the Nuremberg code, and its successors, before she can be entered into a clinical trial. However, concern has been expressed by both patients and professionals about the beneficial or detrimental effect on the patient of asking for her consent. We examine advantages and drawbacks of popular variations on consent, which might reduce the stress on patients at the point of illness. Both informed and uninformed responses to particular trials, and trials in general, are (...) discussed. The selection by doctors of patients, to whom entry to trials will be offered, is explored. (shrink)

OBJECTIVE: To ascertain attitudes to different methods of obtaining informed consent for randomised clinical trials (RCTs). DESIGN: Structured interviews with members of the public, medical secretaries and medical students. SETTING: The public were approached in a variety of public places. Medical secretaries and students were approached in their place of work. SUBJECTS: Fifty members of the public, 25 secretaries and 25 students. MAIN OUTCOME MEASURES: Views on RCTs were elicited, with particular emphasis on how subjects thought the concept of randomisation (...) should be explained. Each participant was presented with descriptions of proposed clinical trials and asked to select his or her preference from a range of options. RESULTS: Written information was preferred over verbal information in 91% of replies. Most respondents (86%) would prefer to sign a consent form. Of the seven statements explaining randomisation, a significant difference was found in favour of explanations that were less explicit about the play of chance (ANOVA; p = 0.0004). Eighty-three per cent of participants thought that randomised trials were morally acceptable when there was no prior medical preference between treatments. However, over half (55%) thought they would find it upsetting to be offered entry in such a trial and a quarter thought the outcome of treatment might be adversely affected. CONCLUSIONS: Our results offer some support for the idea that "economy with truth" is less unsettling than a frank description of the stark reality of what randomisation means. It is a matter of debate as to whether, if we are correct, autonomy should have precedence over beneficence. The offer of entry in a clinical trial is likely to affect the experience of care for many people, especially if the process of randomisation is described explicitly. Potential participants should be given a detailed written explanation of the rationale for the trial and be asked to sign a consent form if they agree to take part. (shrink)