Designing a quality assurance system for dietary data in a multicenter clinical trial: Women's Intervention Nutrition Study

Trisha Copeland, Mary Grosvenor, Diane Crisman Mitchell, Helen Smiciklas-Wright, Virginia Marsoobian, George Blackburn, Barbara Winters

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Reliable dietary intake data are essential for determining outcomes in nutrition-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 Intervention Nutrition Study (WINS), a multicenter clinical trial investigating the effect of reduction of dietary fat intake together with adjuvant systemic therapy on recurrence rates in and survival of postmenopausal women with early stage, surgically treated, breast cancer, has developed a quality assurance system to minimize errors and to produce data that are complete and reliable. The system involves development of standardized procedures for data collection, a quality control program to evaluate the data collected, and continual monitoring and reevaluation. The WINS system is offered as a model for studies collecting dietary intake data, no matter how simple or complex the trial design.

Original languageEnglish (US)
Pages (from-to)1186-1190
Number of pages5
JournalJournal of the American Dietetic Association
Volume100
Issue number10
DOIs
StatePublished - Jan 1 2000

Fingerprint

nutritional intervention
Information Systems
Multicenter Studies
quality control
clinical trials
food intake
Clinical Trials
Dietary Fats
fat intake
Quality Control
breast neoplasms
adjuvants
Survival Rate
Breast Neoplasms
nutrition
Recurrence
therapeutics
monitoring
Therapeutics

All Science Journal Classification (ASJC) codes

  • Food Science
  • Nutrition and Dietetics

Cite this

Copeland, Trisha ; Grosvenor, Mary ; Mitchell, Diane Crisman ; Smiciklas-Wright, Helen ; Marsoobian, Virginia ; Blackburn, George ; Winters, Barbara. / Designing a quality assurance system for dietary data in a multicenter clinical trial : Women's Intervention Nutrition Study. In: Journal of the American Dietetic Association. 2000 ; Vol. 100, No. 10. pp. 1186-1190.
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Designing a quality assurance system for dietary data in a multicenter clinical trial : Women's Intervention Nutrition Study. / Copeland, Trisha; Grosvenor, Mary; Mitchell, Diane Crisman; Smiciklas-Wright, Helen; Marsoobian, Virginia; Blackburn, George; Winters, Barbara.

In: Journal of the American Dietetic Association, Vol. 100, No. 10, 01.01.2000, p. 1186-1190.

Research output: Contribution to journalArticle

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