T. Copeland et al., Designing a quality assurance system for dietary data in a multicenter clinical trial: Women's Intervention Nutrition Study, J AM DIET A, 100(10), 2000, pp. 1186-1190
Reliable dietary intake data are essential for determining outcomes in nutr
ition-related clinical trials. Nevertheless, systems for quality assurance
of dietary intake data are often slighted in the design of such trials and
not incorporated or monitored as the trials continue. The Women's Intervent
ion Nutrition Study (WINS), a multicenter clinical trial investigating the
effect of reduction of dietary fat intake together with adjuvant systemic t
herapy on recurrence rates in and survival of postmenopausal women with ear
ly stage, surgically treated, breast cancer, has developed a quality assura
nce system to minimize errors and to produce data that are complete and rel
iable. The system involves development of standardized procedures for data
collection, a quality control program to evaluate the data collected, and c
ontinual monitoring and reevaluation. The WINS system is offered as a model
for studies collecting dietary intake data, no matter how simple or comple
x the trial design.