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P Riis

Publications and source records attributed to P Riis.

At least 37 records · Page 2Linked to original sources
PubMed2000

The extent of written trial information: preferences among potential and actual trial subjects.

AIM: To investigate the preferred extent of written information in clinical trials among potential and actual trial participants. MATERIALS AND METHODS: Questionnaire survey among citizens of Copenhagen County (PUB, N=508), patients attending an out-patient clinic (OPC, N=200), and finally among participants in two clinical trials (ROC, N=32; MRCRUC, N=47--see Abbreviations). Questions concerned attitudes to and preferences towards a relatively short ("short form") and a more detailed information form ("long form") about a hypothetical, but realistic trial. RESULTS: Approximately 1/8 of the respondents in PUB were satisfied with the "short form", whereas this was the case for approximately 1/6 of outpatients and 1/5 of actual trial participants. Regarding the "long form" approximately three quarters of respondents in all groups were satisfied. Outpatients as a whole were satisfied to a larger extent that respondents from the PUB trial concerning the "short form" (p=0.04). The "long form" was preferred by a little less than 4/5 of respondents in all groups. CONCLUSION: Written information to trial subjects should be detailed, as a majority of both potential and actual research participants prefers this, given the choice between two information forms of different extent on the same trial.

Communication↗
PubMed1999

[How detailed information and how long consideration time do the potential trial subjects want?].

Questionnaires were sent to 508 citizens in Copenhagen county and given to 200 patients attending two out-patient clinics. Questions concerned attitudes and preferences towards either a short or a more detailed information form about an invented trial, and preferences regarding required time for reflection before giving informed consent. One sixth of responders were satisfied with the short form, while about three quarters preferred the long form. Three quarters of the non-hospitalized citizens and the patients from one of the out-patient clinics required at least 24 hours before answering about consent. Among responders in the other outpatient clinic half of the patients only required 15 minutes, or stated that they could answer at once. We conclude that written information to trial patients should be detailed, as a majority of potential research participants prefer this. At least 24 hours should be given before an informed consent is obtained.

Adult↗
PubMed1999

Ethical aspects of clinical trials: the attitudes of the public and out-patients.

OBJECTIVES: To investigate attitudes to clinical research amongst potential research participants. DESIGN: Questionnaire-survey. SETTING: Two medical out-patient clinics and the background population. SUBJECTS: A total of 508 randomly selected citizens in Copenhagen County (64% responded) and 200 consecutive patients attending the out-patient clinics (64% responded). OUTCOME MEASURES: Attitudes toward different aspects of clinical research. RESULTS: Positive attitudes toward medical research were disclosed. The majority found scientific testing necessary, although only a minority considered participation a moral obligation. Both personal benefits and altruistic motives for participation were highly rated, whereas former positive experiences from trial participation had only minor impact on decisions. Several respondents stated former trial participation had changed their attitudes negatively. Lack of feedback of results was of major importance for this change. Attitudes are significantly influenced by the presence of independent research ethics committees, whereas trial technicalities such as drawing lots and blinding was found problematic by only a few respondents. Altruistic motives of physicians to conduct trials were highly rated by a majority of respondents, but the motive of promoting doctors' careers was also judged important. Respondents rated nondiscomforting procedures as acceptable or having only a small impact or strain on their lives. CONCLUSION: Attitudes toward medical research are positive amongst out-patients and the general public. Altruistic and nonaltruistic motives both concerning trial participation and concerning the motives of physicians to conduct medical research were rated highly. Lack of feedback concerning results of trials to participants was important for a negative change in attitude toward participation.

Attitude↗
PubMed1999

Misconduct in clinical research--the Scandinavian experience and actions for prevention.

The Nordic countries, Denmark, Norway, Sweden and Finland, started relatively early with the establishment of national committees dealing with scientific misconduct within the health sciences. They originally included slightly different parts of the dishonesty spectrum, when launching their independent control bodies, but have since then converged, with the end result that all four countries now include all aspects of the spectrum. In other words, the ranges now cover alleged fabrication and plagiarism on one side, and quarrels about authorship and terms of procedure within cooperating groups of scientists on the other. The Nordic experiences have made it possible to estimate a prevalence rate of 1-2 presented cases per million inhabitants, of which only approximately 1/5 is serious. The preventive actions have been publications of guidelines for: scientific co-operation; raw data storage; authorship. Further, educational initiatives include postgraduate courses for senior scientists; postgraduate courses for junior scientists; influence via inquiries and investigations. The Nordic experiences point strongly to the necessity of an independent national control body.

Humans↗
PubMed1999

Ethical, legal and health economic aspects of neonatal screening.

The spectrum of the title of this work is wide, but necessarily so, because of the increasing interaction of the three key components--ethics, law and health economy--in all parts of health systems. Although by nature the key components are different, they are still interdependent. Ethics, as the overall term for values, norms and attitudes of democratic societies, is the basic reference for our controlling of our personal lives, our lives with each other, and our lives with society institutions in the broadest sense. Ethics is the cambrium for control with our general behaviour, but is at the same time the cambrium for the control mechanisms of societies, as expressed in national laws. Health economics is often considered a necessary but value-free part of the spectrum, in accordance with money's very material nature. And yet economics and other resource elements (as organs for transplantation or numbers of special experts) have a strong link to ethics via so-called distributional ethics ("we are able to do more than we can afford"). The main theme for this introduction is ethics. In neonatal screening it relates to two different aspects: one linked to the neonate as an individual who can benefit from early diagnosis of treatable diseases, the other to the neonate as a member of a family line, enabling geneticists later to use the results for genetic mapping of a whole family or of large societal groups.

Denmark↗
PubMed1997

[Basic ethics].

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Denmark↗
PubMed1997

Ethics.

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Bioethical Issues↗