The HERITAGE family study: Quality assurance and quality control

Jacques Gagnon, Michael A. Province, Claude Bouchard, Arthur S. Leon, James S. Skinner, Jack H. Wilmore, D. C. Rao

Research output: Contribution to journalArticlepeer-review

43 Scopus citations

Abstract

The HERITAGE (HEalth, RIsk factors, exercise Training And GEnetics) Family Study is the first multicenter family clinical trial of its kind. Conducted by a consortium of five universities in the United States and Canada, the study has as its primary goal to document the role of the genotype in the cardiovascular, metabolic, and hormonal responses to aerobic exercise. A comprehensive protocol was implemented at four Clinical Centers (CC) for the generation of data on sedentary subjects. This group included 450 caucasians from 90 nuclear families (father, mother, three children) and 200 black subjects from 40 to 100 family units over a 5-year period. The entire family was tested before and after a 20-week exercise training program. The fifth participating center, the Data Coordinating Center (DCC), is responsible for data management and data analysis. A Consortium Coordinating Center (CCC) responsible for the overall coordination and direction of the study was established at the Quebec CC. Quality assurance and quality control are jointly coordinated by the CCC and the DCC. A multicenter study of this magnitude requires careful standardization of all procedures and constant monitoring of quality control at all levels operation. This report describes the quality assurance and quality control measures implemented in the HERITAGE Family Study, including some examples with real data.

Original languageEnglish (US)
Pages (from-to)520-529
Number of pages10
JournalAnnals of epidemiology
Volume6
Issue number6
DOIs
StatePublished - Nov 1996

Bibliographical note

Funding Information:
The HERITAGE Family Study is supported hy the National Heart, Lung and Blood institute through the following grants: HI.45670 (C. Rouchatd); HL47323 (A. S. Leon); HL47317 (D. C. Rae); HL47327 (J. S. Skinner), and HL47321 (J. H. Wilmote). The study IS also supported m part hy grant MOl-RR@O-400 from the National Center for Research Sources to the University of Minnesota Clinical Research Cenrer. Thanks are expressed to all the Co-Principal Investigators, Cure 1 .ahorato~ Directors, Investigators, Co-investigators. Local Project Coordinators, rosearch assts-rants, laboratory technicians, and secretaries who arc contrihurmg to the study. Finally, the entire HERITAGE consortium is v<xry thankful to those hard-working participating families whose involvemrnr demonstrates the feasibility this study

Keywords

  • Exercise training
  • cardiovascular disease
  • diabetes
  • family study
  • genetics
  • quality control
  • sedentary lifestyle

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