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Randomized clinical trials: alternatives to conventional randomization.

The randomized allocation format remains an exceedingly powerful tool for clinical research. Because humans are the subjects in clinical research, this area of scientific study must operate within the limits dictated by such basic principles as individual autonomy, justice, and beneficence. As randomized studies have become more common in clinical research, it has become apparent that there is often need for modification of the basic randomized format or for alternatives. The most widespread modification is the use of sequential analyses to monitor the progress of a trial and ensure early identification of either unanticipated adverse effects or more pronounced differences than expected. Although this modification does not affect the basic randomized allocation format, it does provide a protection that is lacking in the conventional trial and should be utilized whenever feasible. Modifications that do affect the basic structure of the randomized trial include adaptive allocation and pre-randomization. The former is attractive and useful but limited to studies in which results from early enrollees are known before late enrollees are allocated. The greater the linkage between preceding subject results and subsequent assignments, the greater is the protection afforded by such a format. Pre-randomization, more universally applicable than adaptive allocation, suffers from pronounced cross-over potential and has been criticized on ethical grounds, a combination of weaknesses that raises questions of whether pre-randomization truly offers advantages to conventional randomized formats. True alternatives to the randomized format include the self-controlled study and the historical control design. Both possess significant ethical advantages over the simple randomized study. Unfortunately, both are at some methodological disadvantage when the same comparison is made. The self-controlled study is limited to the study of conditions sufficiently stable or recurrent that they permit two or more treatment courses in a single patient. In emergency medicine and critical care, this description fits only a small proportion of the illness spectrum. This design is underutilized in clinical research focused on less severe problems of the type seen in ambulatory and primary-care settings. Such problems can be suitable topics for research by emergency medicine specialists. Historical control studies are eminently applicable in the emergency and critical-care setting.(ABSTRACT TRUNCATED AT 400 WORDS)

Antihypertensive Agents↗

The development of a computer assisted instruction and assessment system in pharmacology.

We describe the construction of a computer based system for instruction and assessment in pharmacology, utilizing a large bank of multiple choice questions. Items were collected from many sources, edited and coded for student suitability, topic, taxonomy and difficulty and text references. Students reserve a time during the day, specify the type of test desired and questions are presented randomly from the subset satisfying their criteria. Answers are scored after each question and a summary given at the end of every test; details on item performance are recorded automatically. The biggest hurdle in implementation was the assembly, review, classification and editing of items, while the programming was relatively straight-forward. A number of modifications had to be made to the initial plans and changes will undoubtedly continue with further experience. When fully operational the system will possess a number of advantages including: elimination of test preparation, editing and marking; facilitated item review opportunities; increased objectivity, feedback, flexibility and descreased anxiety in students.

Anxiety↗

Investigating the effectiveness of self-learning packages in staff development.

The nursing shortage and high patient acuity levels make it difficult for nurses to attend traditional inservice programs. Time and financial constraints affect the staff educator's ability to teach needed topics to large numbers of nursing staff. This study suggests that the use of self-learning packages can be a viable alternative or adjunct to traditional inservice programs for nursing staff development.

Educational Measurement↗

Development of professional competence via self-instructional units.

In recent years, self-instructional teaching methods have come under criticism from educators, much of it warranted. But when self-instructional materials are written by experienced educators who teach the topic and are developed within a versatile process using a proven format, they are extremely valuable teaching aids. We discuss here the results of a grant project funded by W. K. Kellogg Foundation and describe the process used at Kettering Medical Center's School of Medical Technology to develop and produce over 100 self-instructional units. We also discuss potential uses of self-instructional units in professional continuing education programs and suggest ways self-instructional units might be used to promote interdisciplinary health care and expansion of professional knowledge banks. This project confirmed that professions can create their own educational materials through the independent efforts of their members.

Curriculum↗

Facilitator not teacher: a role change for tutors in open learning nursing education.

Open learning is now an established, if rapidly changing, part of post-compulsory education and training in the United Kingdom. It has also developed in significant ways within nurse education. A key role in successful open learning is that of the tutor. Differences between the activities of teaching and facilitation are defined and ways of mapping the tutor's role within these are suggested. Differences in approach can be clustered around the topics of: the locus of control; learning methodology; the learning context and media; and the curriculum. These are discussed in turn to elicit what are the key issues for tutoring in relation to each one.

Curriculum↗

Effective development and utilization of self-learning modules.

This article provides guidelines to assist the nurse educator in designing self-learning modules for appropriate topics and learners, in creating the module, and in developing tools to evaluate the effectiveness of the module. By following the guidelines presented, the nurse educator can create cost-effective learning opportunities for professional nurses. Utilization of self-learning modules encourages nurses to be self-directed and allows the nurse educator to be the resource rather than the source of learning.

Cost-Benefit Analysis↗

Distance learning in a local setting: a structured learning course for the introduction of general practice to undergraduate students.

This paper describes the development and evaluation of a structured introductory course in general practice. Following some of the principles developed in distance education, the Department provides everything the student needs for the formal learning requirement as well as detailed assistance in how best to tackle the selected topics. The course was reported to be demanding, relevant and enjoyable. The major areas requiring attention were in reducing the amount of reading required, more help in learning to work in small student-run groups and more one-to-one supervision of physical examination skills. With further refinement the course should be applicable to other medical schools in developed countries.

Curriculum↗

Problem-based learning variant: transition phase for a large institution.

OBJECTIVE: To compare students' test scores and perceptions of problem-based learning (PBL) and lecture-based learning (LBL) by applying a PBL-variant. METHOD: For the transition from LBL to PBL, PBL was varied for one discipline only and for a large group of students. Two hundred forty nine second year medical students were taught a topic of Biochemistry by the LBL method and then 141 of these were taught another topic by the PBL-variant. At the conclusion of each topic an MCQ test was given. One week later a 9 item questionnaire was given to the 50 students now attending classes to assess their perceptions of the 2 teaching formats. The test scores of the two methods were compared. Students' ratings were differentiated by the Wilcoxon Signed-Rank test. RESULTS: There was no significant difference in the test scores by PBL or LBL, but PBL received significantly higher student ratings (p < 0.05) than LBL in self-study time, library time, number of books and computer consulted, enthusiasm for the topic, group discussion, depth of knowledge and interest taken in the teaching format. But there was no significant difference in students' ratings of the teacher's importance in either PBL or LBL. CONCLUSION: PBL variant and LBL produced similar MCQ test scores but the former is more conducive to enthusiastic self-study. Thus in the transition phase, PBL may be applied to one discipline and a large group of students without undermining its merits.

Biochemistry↗

Reading illustrated science texts: a micro-computer based investigation of children's strategies.

Research has shown that the effect of illustrations on children's learning of science is related to ability. This study examines the hypothesis that children who show different levels of success in a learning task will employ different strategies in their picture-text processing. One hundred and eighty 14 year-old children were required to learn three illustrated science topics of different levels of difficulty which were presented to them on a BBC micro-computer. The computer was programmed to record the time spent on each sentence and each picture, as well as the point in the text at which the picture was accessed. Post hoc testing enabled the children to be divided into six groups according to their success rates on the learning tasks. Significantly longer times were spent looking at the pictures as the topics increased in difficulty; also the amount of time spent looking at pictures increased as the learning of the children decreased. For every second the least successful children spent accessing pictures, they spent about four seconds reading the text; for the most successful children this ratio was about one-to-six. The least successful children also accessed the pictures significantly more frequently than the most successful. The different strategies used by the children are discussed in terms of what is known about their differential learning gains from illustrated texts.

Adolescent↗

Influence of programmed textbook review on American Board of Surgery In-service Examination scores.

Documentation of academic achievement throughout training is an essential component to residency accreditation. Resident performance evaluations by attending staff provide good assessments of affective behavior and technical skills, but evaluation of surgical knowledge is often subjective in nature. The American Board of Surgery In-Service Examination has become the standard by which academic performance is measured. Numerous types of educational programs are used to increase the knowledge base of residents. Sporadic reading of a standard surgical text is a common part of many residency programs. In 1981, the Michigan State University/Butterworth Hospital General Surgery Residency opted to drop the surgical text reading in favor of a review of specific topics attuned to resident needs. Results of the 1982 American Board of Surgery (ABS) examination identified a significant decrease in percentile scores and average resident performance. A program requiring a systematic review of a standard surgical text was then initiated. This review involved assigned reading and administration of weekly examinations covering each assignment. Following institution of this program, a dramatic improvement in the total average scores for the entire resident group was noted. Similar improvement was noted in individual group scores (PG I, II, III, IV, and V). Results of this study indicate that reading of a standard surgical text should be a required part of each residency program.

Achievement↗

Impact of problem-based learning on residents' self-directed learning.

OBJECTIVE: To examine the effect of a problem-based learning (PBL) curriculum on self-directed learning behaviors among a group of pediatric residents. METHODS: A controlled comparison study was conducted with 80 pediatric residents at a large urban academic medical center. Residents were observed over 3 distinct but consecutive periods. First, all residents participated in a 3-month-long daily lecture series (pre-exposure phase). Then, for another 3 months, 39 residents (PBL group) were exposed to twice-weekly PBL sessions while 41 residents continued with the daily lectures (lecture-based group) and served as controls. Problem-based learning was withdrawn after 3 months and all residents returned to the lecture series (follow-up phase). Residents' self-directed learning behaviors were assessed through self-administered questionnaires during the pre-exposure, exposure, and follow-up phases. RESULTS: There were no significant preexposure differences in self-directed learning behaviors between the groups. During the exposure phase, the PBL group had significantly higher self-directed learning: 5 or more hours of independent study (26% vs 7%) [corrected] (P=.001); 5 or more hours of medical discussions (28% vs 4%) (P=.008); 2 or more computer literature searches (51% vs 30%) (P=.005); and total hours of self-study per week (6 vs 4 hours) (P<.05). At the 3-month follow-up, the PBL group had returned to baseline levels of self-directed learning and there were no significant differences between the groups. CONCLUSION: Residents exposed to PBL engaged in significantly higher levels of self-directed learning than their counterparts.

Adult↗