Introduction Due to the increasing number of clinical trials conducted globally, there is a need for quality continuing education for health professionals in clinical research manager (CRM) roles. This paper describes the development, implementation, and evaluation of a distance-based continuing education program for CRMs working outside the United States. Methods A total of 692 applications were received from CRMs in 50 countries. Of these, 166 were admitted to the program in two cohorts. The program, taught online and in English, included four required and one optional course. Course materials were also provided as hard copies and on CDs. A pretest/posttest design was used to evaluate the outcome of the program in terms of changes in knowledge, participants’ capacity-building activities at their research sites; and participant and supervisor perceptions of program impact. Results Participants demonstrated significant improvements in knowledge about clinical research, rated course content and teaching strategies positively, and identified the opportunity for interactions with international peers as a major program strength. Challenges for participants were limited time to complete assignments and erratic internet access. Participants offered capacity building programs to 5061 individuals at their research sites. Supervisors indicated that they would recommend the program and perceived the program improved CRM effectiveness and site research capacity. Findings Results suggest that this type of continuing education program addresses a growing need for education of CRMs working in countries that have previously had limited involvement with global clinical trials.
Background/AimsIntestinal lavage (IL) administration immediately before capsule enteroscopy (CE) is superior to lavage the day before the procedure. We aimed to determine the effect of IL timing on CE diagnostic yield.MethodsPatients referred for CE were randomized prospectively into two equal groups according to the timing of IL with 2 L of polyethylene glycol solution. Group A and B underwent IL over 2 hours beginning 14 and 4 hours, respectively, before the scheduled CE. The primary outcome measure was preparation quality, measured with a predetermined validated grading scale.ResultsA total of 34 patients were randomized. The frequency of mucosal abnormalities (77% vs. 82%, p=not significant [NS]) and diagnostic yield (47% vs. 53%, p=NS) were similar between the two groups. Moreover, no significant association between the quality of small bowel preparation and the timing at which the purgative for IL was administered was observed (overall fluid transparency, p=0.936; overall mucosal invisibility, p=0.091).ConclusionsDay-before IL is equivalent to same-day IL in terms of overall preparation quality, proportion of complete studies to cecum, small bowel transit time, frequency of identified mucosal abnormalities, and overall diagnostic yield.
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