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Cancer patients asked to participate in a randomised trial including chemotherapy at two university centres and a satellite centre were interviewed about perceptions and experiences (14 trial participating and 15 trial declining patients). The central phenomenon was a constant, cautious balancing of personal options searching for maximised effect, personal safety, trust, confidence and being cared for. Almost all developed a treatment preference and this was decisive for choices. Trial participants strongly wished to get the experimental treatment perceived as superior. They felt their freedom of choice being limited by randomisation. In contrast, trial decliners almost all focused on graver adverse effects related to the experimental treatment. A trusting and confident doctor-patient relationship was valued strongly. Yet, most breast cancer patients treated at the two large centres experienced a general lack of personal trust, confidence and being taken care of. The major reason was patients meeting too many physicians perceived as incompetent and unprepared. In contrast, the ovarian cancer patients treated at the satellite centre were content and satisfied with the main reason being the low number of physicians who were perceived as prepared, empathetic and knowledgeable. All patients expressed a feeling of “loneliness of autonomy” lacking sufficient knowledge and other resources to make educated choices. [ABSTRACT FROM AUTHOR]

Background: To evaluate the use of low-field magnetic resonance imaging (MRI) in active inflammatory bowel disease (IBD). Methods: MRI was executed in a consecutive cohort of 28 patients with Crohn disease (CD) and in 17 with ulcerative colitis (UC) prior to glucocorticoid treatment (1 mg prednisolone orally/kg body weight/day). MRI was repeated after 2-3 weeks (22 CD, 12 UC), and again after treatment completion or prior to surgery (18 CD, 6 UC). Five bowel segments were evaluated separately. MRIs were blindly evaluated by two observers, and findings compared with 39 leucocyte scintigraphies, 38 endoscopies, 15 double-contrast barium enemas, 66 small-bowel radiographic examinations and surgery in 23 patients. Results: In CD, blinded evaluation revealed a kappa (κ) of 0.84 (95% confidence interval (CI) 0.78-0.91). In UC, κ was 0.66 (95% CI 0.55-0.78). Agreements regarding disease extension between MRI and other modalities in CD were found in 345 bowel segments out of 391 (88.2%) at risk, and in UC in 209/235 (88.9%). Colonic disease activity gradings by radiography and endoscopy correlated significantly with T2-signal intensity (SIT2) and increments in T1-signal intensity (%SIT1) in both diseases. Significant correlations between MRI indices of disease activity and CDAI in CD (MRI-SIT2: P < 0.0001; MRI% SIT1: P = 0.0008) and the Powell-Tuck index in UC (MRI% SIT1: P = 0.008) were found. Conclusions: With low interobserver variation and high concordance of findings with other examinations, low-field MRI seems a valuable modality in active IBD. In addition, MRI expressions of disease activity correlate to clinical, radiographic and endoscopic disease activity. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The aim of this study was to compare the treatment efficacies of subcutaneous interferon-α-2A (IFN-α- 2A) injections versus prednisolone enemas in active left-sided ulcerative colitis in an open-labeled, randomized study. METHODS: Sixteen ulcerative colitis patients received IFN-α- 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-α-2A group and all 16 in the prednisolone enema group completed the treatment. RESULTS: IFN-α-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-α-2A treatment were seen during the first 2-4 wk of treatment. CONCLUSION: lFN-α-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-α-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. [ABSTRACT FROM AUTHOR]

Abstract. Madsen SM, Holm S, Davidsen B, Munkholm P, Schlichting P, Riis P (Copenhagen University Hospital in Herlev, Slagelse County Hospital, Slagelse, Hvidovre Hospital, University of Copenhagen, Denmark and University of Manchester, UK). Ethical aspects of clinical trials: the attitudes of participants in two non-cancer trials. J Intern Med 2000; 248: 463–474. 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-α-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. [ABSTRACT FROM AUTHOR]

Background: Patients suspected of having perianal suppurative disease often undergo a combination of several potentially painful, invasive procedures to establish or rule out the diagnosis. To evaluate the accuracy of low-field magnetic resonance imaging (MRI) in distinguishing patients with active anal fistulae and patients with no active fistulation we performed a retrospective study. Methods: Fifty-six patients suspected of having anal fistulation were evaluated in the surgical outpatient clinic. Patients were examined with low-field MRI (0.1 T; gradient echo technique, TR/TE 1500/40 and TR/TE 115/25, +/- gadodiamide (0.1 mM/kg intravenously)) in both coronal and axial planes, using a body quadrature coil. Altogether 71 MRIs were performed. In selected patients evaluation included endoanal ultrasonography, fistulography, and/or surgery. On the basis of the combined results of all available follow-up data for 6 months after the MRI, patients were placed in groups either having active fistulation or not. Results: MRI findings agreed with the combined findings of other examinations in 54 patients. Active or possibly active fistulae were found in 36 cases, whereas 33 patients showed no active fistulae. The kappa value is 0.944 (95% confidence limits, 0.866-1.021). In two patients the MRI findings disagreed with the combined findings of the other modalities. Conclusion: The use of low-field MRI of the pelvic region in the investigation of suspected perianal fistulae is a feasible, reliable, and painless examination. MRI should be considered in patients with suspected complex anal fistulae. Future prospective studies are warranted. [ABSTRACT FROM AUTHOR]

A patient with active Crohn disease was evaluated by MRI at admission, clinical remission, and a new relapse. The MRI-estimated disease extension correlated with surgical findings, whereas ultrasonography underestimated and a small bowel series overestimated the extension. MRI disclosed the disappearance of intestinal edema at the time of clinical remission and, in contrast to ultrasonography, showed an abscess and a fistula, confirmed by surgery, at the new relapse. [ABSTRACT FROM AUTHOR]

Examines the use of low-field magnetic resonance imaging (MRI) in crohn disease and ulcerative colitis. Assessment of activity in inflammatory bowel disease; Comparison of disease with non-disease bowel segments with segments from healthy controls; Characteristics of chronic inflammatory bowel disease.

The article focuses on the characteristics of a Lactococcus lactis strain deficient in intracellular clpP and extracellular HtrA proteases. The strain, called clpP-htrA, could be construction through the conjugation between a clpP donor strain and an htrA recipient strain in the ZN9000 context. It allows heterologous gene expression under the control of nisin-controlled expression system.