Preventive medicine
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Preventive medicine · Jan 1998
Randomized Controlled Trial Clinical TrialWorksite health and safety climate: scale development and effects of a health promotion intervention.
Environmental influences on health and health behavior have an important place in research on worksite health promotion. We tested the validity and internal consistency of a new measure of organizational health and safety climate that was used in a large randomized trial of a worksite cancer prevention program (the Working Well Trial). The resulting scales then were applied to assess intervention effects. ⋯ The health and safety climate scales developed for this study provide useful instruments for measuring organizational change related to worksite health promotion activities. The Working Well Intervention resulted in a significant improvement in worksite health climate.
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A well-designed, adequately funded clinical trial based on sound science and conducted by experienced investigators and staff can falter if participating trial clinics are not managed well. Ten commandments for successful trial clinic management address key organizational and operational issues. Commandment I: Thou shalt know and follow thy rules. ⋯ Commandment X: Thou shalt know and accept thy limitations. This report puts these commandments into context by providing concrete examples in the clinical trial setting. These commandments could serve as guidelines to the spectrum of personnel involved in the operations of a trial clinic, namely, principal investigators and co-investigators, trial coordinators, data managers, technicians, administrators, and support staff.