摘要：The overwhelming evidence about the role lifestyle plays in mortality, morbidity, and quality of life has pushed the young field of modern health promotion to center stage. The field is beset with intense debate about appropriate evaluation methodologies. Increasingly, randomized designs are considered inappropriate for health promotion research. We have reviewed criticisms against randomized trials that raise philosophical and practical issues, and we will show how most of these criticisms can be overcome with minor design modifications. By providing rebuttal to arguments against randomized trials, our work contributes to building a sound methodological base for health promotion research. COMPELLING EVIDENCE about the critical role lifestyle and environmental factors play in mortality, morbidity, and quality of life has contributed to the growing popularity of the field of health promotion, which has an overarching aim of “enabling people to increase control over, and improve, their health.” 1 (p1) Because of the multidisciplinary nature of health promotion, research is influenced by many fields, including education, policy, social science, anthropology, and epidemiology. 2 While the randomized controlled trial (RCT) is the gold standard in today’s medical world, the role randomization plays in health promotion research is a topic of hot debate, which in part reflects the ongoing debate in nonmedical fields about the relevance of randomized trials. 3 – 7 Many health promotion researchers have asserted that RCTs are irrelevant to, or unworkable in, their field for a variety of philosophical and practical reasons. 8 – 10 We refute the philosophical arguments and present approaches to handling the practical issues. Although we do not claim that all the practical problems can be entirely eliminated, we submit that a wisely designed RCT is a far superior evaluative mechanism for answering specific types of questions compared with the evaluation approaches that are currently popular in the health promotion field. Our recent field study of a hygiene health promotion program in Jerusalem preschools is an illustrative example. This study was a controlled trial with randomization at the preschool level: 40 preschools were randomized equally to either intervention or control. 11 The program addressed various hygiene issues, with a primary emphasis on hand washing. The program used a multi-pronged approach that included elements aimed at staff, children, parents, and school nurses, as well as hygienic changes to the classroom environment. A total of 1029 children participated in the trial. The program was implemented in the intervention preschools during December 2000. Data on absenteeism due to illness was collected from children in both groups from January 2001 through April 2001. In May 2001, the program was implemented in the control preschools. Thus, all participating preschools eventually received the program in a “phased” manner. This design technique, which is better known for being used with individual randomization schemes, contributed considerably to the success of the trial. Details about this design technique have been published elsewhere. 12 , 13
