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P Riis

Publications and source records attributed to P Riis.

At least 19 recordsLinked to original sources

Attitudes towards clinical research amongst participants and nonparticipants.

OBJECTIVES: To investigate attitudes to clinical research amongst cancer trial participants and nonparticipants, and to compare results with those from previous studies amongst participants in noncancer trials. DESIGN: Trial participating respondents were given three questionnaires during the clinical trials. Respondents amongst patients declining randomization answered a single questionnaire. SETTING: Participants and nonparticipants in randomized clinical cancer trials. SUBJECTS: Forty-one participants and 47 nonparticipants in cancer trials. RESULTS: Altruistic motives of physicians to conduct medical research were highly rated. Attitudes towards clinical research were positive in all groups, with nonparticipant respondents being the least positive. Eight to nine tenths found scientific testing necessary before general health service implementation. Trial participants were, as compared with nonparticipating respondents, more positive towards both participation of self and others. Both personal and altruistic motives for participation were highly rated. Primary reasons for nonparticipation were fear of 'the unknown' and/or unease with randomization. Only a minority felt a moral problem created by declining trial participation. Respondents amongst noncancer participants were more satisfied with the information given than both cancer participants and cancer nonparticipants. Negative experiences in cancer participants generally dealt with frustration related to seeing too many physicians at check-up appointments. CONCLUSION: Attitudes towards clinical research are generally positive even in cancer nonparticipants. Both personal and altruistic motives for participation were highly rated. A fear of 'the unknown' and resentments towards randomization were primary reasons to renounce participation. Seeing too many physicians at check-up appointments seems to be an important factor for negative experiences in cancer trial participants.

Adult↗

An open-labeled, randomized study comparing systemic interferon-alpha-2A and prednisolone enemas in the treatment of left-sided ulcerative colitis.

OBJECTIVE: The aim of this study was to compare the treatment efficacies of subcutaneous interferon-alpha-2A (IFN-alpha-2A) injections versus prednisolone enemas in active left-sided ulcerative colitis in an open-labeled, randomized study. METHODS: Sixteen ulcerative colitis patients received IFN-alpha-2A subcutaneously (dosage: first wk, 9 MIU three times weekly [t.i.w.]; second wk, 6 MIU t.i.w.; wk 3-12, 3 MIU t.i.w.), and 16 received prednisolone enemas for 30 days (100 ml once daily, 0.25 mg of prednisolone/ml). The Powell-Tuck Index, Inflammatory Bowel Disease Questionnaire (IBDQ) score, and rectal histological activities were assessed before and after treatment. Thirteen patients in the IFN-alpha-2A group and all 16 in the prednisolone enema group completed the treatment. RESULTS: IFN-alpha-2A treatment showed significant improvements in the Powell-Tuck Index (p = 0.0002), IBDQ score (p = 0.002), and rectal histological activity scores (p = 0.02). In the enema group, significant improvements were found in the Powell-Tuck Index (p = 0.0009), whereas no significant improvements were detected in the IBDQ scores (p = 0.055) or rectal histological scores (p = 0.052). There were no differences between scores of the two groups either before or after treatment. Only moderate side effects from the IFN-alpha-2A treatment were seen during the first 2-4 wk of treatment. CONCLUSION: IFN-alpha-2A treatment resulted in significant depression of the disease activity as reflected by the Powell-Tuck Index, IBDQ score, and histological disease activity scoring. The preliminary trial thus suggests that IFN-alpha-2A may be effective in the treatment of active left-sided ulcerative colitis. Larger, randomized trials are, however, warranted to confirm this finding, owing to possible type II errors in group comparisons.

Adult↗

Scientific dishonestry: European reflections.

Scientific dishonesty has attracted increased attention around the world during the past three to four decades. Europe became aware of the problem later than the USA, but has within the past 10 years created national control systems for all biomedical projects, not only those supported by public money. The prevalence of the problem can only be calculated indirectly by referring to population figures as denominators. Measured this way, figures from Denmark as a whole show: 1-2 cases referred/million inhabitants/year, 1 case treated/million inhabitants/year, 1 case of scientific dishonesty/million inhabitants/5 years. For Finland, 1-2 cases were referred/million inhabitants/1-2 years; for Norway, similar figures of 1/4 million inhabitants/year were calculated. Figures from the Danish national independent control body 1993-7 show the distribution of the types of cases that were charged, with numbers of confirmed cases in parentheses: fabrication, 2 (1); plagiarism, 3 (0); theft, 2 (0); ghost authorship, 2 (1); false methodological description, 3 (1); twisted statistics, 2 (0); suppression of existing data, 4 (0); unwarranted use of data, 4 (0); and authorship problems, 8 (1). This survey emphasises the need for national guidelines, an independent national control body, and initiatives for strong preventive actions.

Authorship↗

[Humanities and art as a part of medical education].

From superstition and witchcraft, to detailed scientific insight into the human body in health and disease: Stupendous though the development of medical science has been over the last few centuries, it does not in itself give doctors a sufficient basis for meeting their patients and the people around them. In these interpersonal encounters, fundamental, immaterial values are the all-important basis. These values and their place in life are not visible in science itself, hence the humanities and the arts offer approaches and inspiration that are of the greatest value in the education of doctors at all levels.

Education, Medical↗

[What is the special Nordic in medicine?].

Nordic health professionals often hear the term "the Nordic model" when visiting countries outside the Nordic ones. Such a Nordic model is most often related to selected aspects like the doctor-patient-relationship, the structures and functions of the Nordic health systems, and the Nordic establishments of independent, nationwide control systems dealing with research ethics and research honesty within the biomedical sciences. In the present essay the background for such a conception of special Nordic characteristics within medicine and health services is evaluated through an observation window. The conclusion is that the majority of individual components of the Nordic health sectors, including education and research, are by nature global, but that the weighting and the projection to clinical work and research shows decisive traits, especially related to patients' rights and ethics. On this background it seems legitimate to accept the surrounding world's impression of a special Nordic model.

Delivery of Health Care↗

[What is specifically Nordic in medicine?].

Nordic health professionals often hear the term "the Nordic model" when visiting countries outside the Nordic area. This Nordic model is usually related to selected aspects like the doctor-patient-relationship, the structures and functions of the Nordic health systems, and the independent, nationwide control systems in the Nordic countries which deal with research ethics and integrity in research within the biomedical sciences. In this essay the concept of specifically Nordic characteristics within medicine and health services is evaluated through an observation window. The conclusion is that the most components of the Nordic health sectors, including education and research, are by their very nature global, but that their weighting and the projection to clinical work and research show decisive traits, especially related to patients' rights and ethics. On this background, it seems legitimate to accept the surrounding world's impression of a special Nordic model.

Delivery of Health Care↗

Sociology and psychology within the scope of scientific dishonesty.

A survey is undertaken based on qualitative analyses of the cases of scientific misconduct from the Danish Committee on Scientific Dishonesty's first five years of collecting data, with additional information from selected international sources, in which underlying psychological motivations can be judged.

Denmark↗

Ethical aspects of clinical trials: the attitudes of participants in two non-cancer trials.

OBJECTIVES: To investigate attitudes to clinical trials in non-cancer trial participants. DESIGN: Questionnaires at entry, during, and after participation in a clinical study. SETTING: Participants in: (i) ROC: a clinical study comparing systemic interferon-alpha-2A treatment vs. prednisolone enemas in ulcerative colitis; and (ii) MRCRUC: a clinical study investigating low-field magnetic resonance imaging as a new modality for the evaluation of patients with inflammatory bowel disease. SUBJECTS: Thirty-two patients in ROC and 47 patients in MRCRUC. OUTCOME MEASURES: Attitudes towards different aspects of clinical research. RESULTS: The majority found scientific testing of clinical methods necessary, having positive attitudes towards both participation by themselves and others. The creation of a personal moral problem by denying participation was rejected by a large majority, and still both personal and altruistic motives for participation were highly rated. An important motive for accepting inclusion was the expectation of being 'a special patient' during the trial. The presence of research ethics committees controlling clinical research had a significant positive impact on decisions to participate, and drawing lots and blinding were found problematic by only a minority. Patients valued their satisfaction with participation in the trials highly, and would almost all accept a request to participate in future trials. The most important reason for this was a feeling of receiving better care and information than expected outside a trial setting, primarily determined by the patients seeing only one physician during the trials. A pronounced wish to obtain follow-up information was expressed. CONCLUSION: Attitudes towards medical research are positive with both altruistic and nonaltruistic motives for participation. Expectations of being treated as 'a special patient' in the trial were important in accepting to participate. Seeing the same physician at control visits was an important factor for satisfaction with participation.

Adult↗