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Background:
Studies suggest that the process of patient consent to clinical trials is sub-optimal. Participant information sheets are important but can be technical and lengthy documents. Performance-based readability testing is an established means of assessing patient information, and this study aimed to test its application to participant information for a Phase 3 trial.
Methods:
An independent groups design was used to study the User Testing performance of the participant information sheet from the Phase 3 ‘Poor Responders’ trial of In Vitro Fertilisation (IVF). 20 members of the public were asked to read it, then find and demonstrate understanding of 21 key aspects of the trial. The participant information sheet was then re-written and re-designed, and tested on 20 members of the public, using the same 21 item questionnaire.
Results:
The original participant information sheet performed well in some places. Participants could not find some answers and some of the found information was not understood. In total there were 30 instances of information being not found or not understood. Answers to three questions were found but not understood by many of the participants, these related to aspects of the drug timing, Follicle Stimulating Hormone and compensation. Only two of the 20 participants could find and show understanding of all question items when using the original sheet. The revised sheet performed generally better, with 17 instances of information being not found or not understood, although the number of ‘not found’ items increased. Half of the 20 participants could find and show understanding of all question items when using the revised sheet. When asked to compare the versions of the sheet, almost all participants preferred the revised version.
Conclusions:
The original participant information sheet may not have enabled patients fully to give valid consent. Participants seeing the revised sheet were better able to understand the trial. Those who write information for trial participants should take account of good practice in information design. Performance-based User Testing may be a useful method to indicate strengths and weaknesses in trial information.
Background:
The internationally mandatory complement fixation test (CFT) for testing of equine sera for the absence of glanders has repeatedly led to discrepant results. Not only do “false positive” sera pose a problem for the diagnostician and the animal health authorities but they can also result in significant financial losses for the animal owners.Due to the very low prevalence of glanders in the horse population it is of major importance to use tests with a high specificity to overcome unreliable predictive values. We have compared formalin-fixed B. mallei whole cell antigen and a well characterised mouse monoclonal antibody with regard to their specificity and sensitivity for glanders serodiagnosis using CFT, an indirect (i) and a competitive (c) ELISA platform. Results: Our results show that the CFT is still a very reliable technique in horse populations with very low glanders prevalence. The cELISA has a high sensitivity and specificity comparable to that of the CFT. The cELISA offers the possibility for automatisation, can be applied to non-complement fixing sera and used for various host species. Conclusions: The CFT is still the method of choice for testing horses for the absence of glanders.
Background:
Aesthetics is a main goal of both conservative and surgical treatments in adolescent idiopathic scoliosis (AIS). Previously, we developed and validated a clinical scale – the Aesthetic Index (AI)–in order to measure aesthetic impairment and changes during treatment.Aim: To verify the efficacy of bracing on aesthetics in AIS.Study Design: Prospective Cohort Study.Population: Thirty-four consecutive patients, age 13.2+/-3.7, initial Cobb Angle 32+/-12degrees, ATR 10+/-4degrees Bunnel, 11 males.
Methods:
Patients with AI scores of at least 5/6 were included. Each of them had a brace prescription (18 to 23 hours per day), according to the SPoRT concept. AI was measured again after six months and at the end of treatment, and then the pre- and post-treatment scores compared. The Wilcoxon test was performed.
Results:
Twenty-nine patients out of the 34 included completed the treatment and had six-month and final results; four patients were lost during the treatment, and one was fused. At baseline, median AI was 6 (95% IC 5-6) but the score decreased to 3 (95% IC 0-5; p<0.05) after six months with brace, and this value was maintained in the 29 who completed the treatment (95% IC 1-6; p<0.05 with respect to the baseline).
Conclusion:
Aesthetics can be improved in a clinically significant way when the brace treatment is performed according to the SPoRT concept and by following the SOSORT management criteria. This is a relevant result for patients and a major goal of scoliosis treatment, be it conservative or surgical. The use of a more sensitive tool like TRACE could more easily detect the clinical changes; nevertheless, AI proved sensible enough that its use in everyday clinical practice can be suggested.
Background:
Imported malaria occurs as a relatively rare event in developed countries. As a consequence, most clinicians have little experience in making clinical assessments of disease severity and decisions regarding the need for parenteral therapy or high-level monitoring. In this study, the diagnostic accuracy of procalcitonin (PCT) for severe Plasmodium falciparum disease was assessed in a cohort of 100 consecutive travellers with various species of imported malaria.Methods and resultsIn all patients, PCT was measured on admission with a semi-quantitative ‘point-of-care’ test. Patients with severe P. falciparum malaria had significantly higher median PCT levels on admission as compared with patients with uncomplicated P. falciparum disease. In addition, PCT levels in patients with non-falciparum malaria were also higher compared with patients with non-severe falciparum malaria but lower compared with severe P. falciparum malaria. At a cut-off point of 10 ng/mL, PCT had a sensitivity of 0,67 and a specificity of 0,94 for severe falciparum disease. However, at lower cut-off points the specificity and positive predictive value were rather poor although the sensitivity and negative predictive value remained high.DiscussionPotential drawbacks in the interpretation of elevated PCT levels on admission may be caused by infections with non-falciparum species and by concomitant bacterial infections.
Conclusion:
Semi-quantitative determination of PCT on admission is of limited use in the initial clinical assessment of disease severity in travellers with imported malaria, especially in settings with limited experience with the treatment of malaria.