A new course on hypothesis and protocol development

Abstract

Context and setting The study hypothesis is central to research. However, although medical schools commonly teach statistical hypothesis testing, to our knowledge, the development of the hypothesis itself and its critical relation to subsequent activities in the research investigation are relatively overlooked in standard methodology curricula. Why the idea was necessary Largely because of inadequate preparation, many doctors fail to understand the importance of the hypothesis and therefore lack a coherent conceptual framework to guide initiation, execution and proper interpretation of their own research. What was done To help address these problems at our institution (Weill Medical College, Cornell University, New York), we designed and implemented a new course, the objective of which was to ‘provide a conceptual framework for understanding principles involved in hypothesis development and protocol design, based on a pre-specified hypothesis’. This course, a spin-off from our longstanding comprehensive course on research methodology, is a core component of the new Master's degree/certificate programme in clinical investigation (K30 Award) offered here. It is taught once weekly for 15 weeks by faculty from the Departments of Medicine and Public Health to students in the programme (18 fellows and junior attending doctors during its first year [2005–06]) and to a number of doctor auditors. The curriculum emphasises the scientific method and its relation to hypotheses and inferences, and guiding principles for identifying and evaluating research questions, constructing and ‘operationalising’ research hypotheses, selecting appropriate research designs, managing data, developing protocols, and writing a publishable paper based on evaluation of a hypothesis. Topics are presented as 12 1-hour interactive lectures with frequent, planned question-and-answer periods and interspersed exercises based on liberal use of clinical examples. Lectures are integrated with 3 60–90-minute workshops where participants work in small groups to generate research questions; formulate, examine and defend hypotheses as tentative answers to these questions (1 workshop), and write ‘miniprotocols’ based on these hypotheses (2 workshops). This mixed pedagogical approach was selected to: promote exposure to and intellectual engagement with a broad array of new concepts in a relatively short time frame; permit their application, and enable faculty to gauge concept acquisition. Each student's final project requires the student to design a protocol in his or her area of interest, embodying concepts and principles introduced in the course. After the final session, participants complete a formal evaluation instrument to assess course quality and perceived benefit. Evaluation of results and impact The course has been well received (average ratings for 2005–06 > 4.0/5 [good to excellent] and positive commentary) and will be repeated annually. Students unanimously indicated that it satisfied its educational objectives and judged the lectures and workshop on hypothesis development to be especially valuable for enhancing their ability to conduct research. Faculty observation of student performance at workshops and other didactic sessions indicated increased understanding of the research hypothesis and related methodology over the instructional period. Our experience shows it is feasible to teach the fundamentals of hypothesis and protocol design to doctors through interactive lectures and workshops, with a high level of perceived benefit and participant satisfaction. Future plans call for formal evaluation of additional learning outcomes.