TY - JOUR
T1 - The diabetes prevention program
T2 - Recruitment methods and results
AU - Rubin, Richard R.
AU - Fujimoto, Wilfred Y.
AU - Marrero, David G.
AU - Brenneman, Tina
AU - Charleston, Jeanne B.
AU - Edelstein, Sharon L.
AU - Fisher, Edwin B.
AU - Jordan, Ruth
AU - Knowler, William C.
AU - Lichterman, Lynne C.
AU - Prince, Melvin
AU - Rowe, Patricia M.
N1 - Funding Information:
We are indebted to the thousands of persons who volunteered to participate in the DPP. Funding was provided by the National Institutes of Health through the National Institute of Diabetes and Digestive and Kidney Diseases, the Office of Research on Minority Health, The National Institute of Child Health and Human Development, and The National Institute on Aging. In addition, The Indian Health Service, the Centers for Disease Control and Prevention, The American Diabetes Association, and two pharmaceutical companies, Bristol-Myers Squibb and Parke-Davis, contributed support. All support to the clinical centers and the Coordinating Center was provided through the NIDDK using the mechanism of the Cooperative Agreement, except for the Southwestern American Indian Center, which was supported directly by the NIDDK and the Indian Health Service. We acknowledge the General Clinical Research Centers that assisted in the conduct of the DPP.
PY - 2002
Y1 - 2002
N2 - The Diabetes Prevention Program (DPP) is a multicenter randomized controlled trial designed to test whether diet and exercise or medication can prevent or delay the onset of type 2 diabetes in persons with impaired glucose tolerance, who are at increased risk of the disease. This paper describes DPP recruitment methods, strategies, performance, and costs. The DPP developed an organizational structure for comprehensive management and continuous monitoring of recruitment efforts. The DPP utilized a variety of recruitment strategies, alone or in combination, and a stepped informed consent procedure leading to randomization. Studywide and clinic-specific recruitment data were monitored, analyzed, and used to modify recruitment approaches. DPP recruitment was completed slightly ahead of schedule, meeting goals for the proportion of women enrolled and nearly meeting goals for the proportion of racial/ethnic minorities. Clinics varied widely in the recruitment strategies they used, and these strategies also varied by participant age, gender, and race/ethnicity. Staff time devoted to recruitment averaged 86.8 hours per week per clinic, with the majority of effort by staff specifically assigned to recruitment. The number of staff hours required to recruit a participant varied by recruitment strategy. Recruitment cost (excluding staff cost) was about US$1075 per randomized participant. The DPP experience offers lessons for those planning similar efforts: (1) a method for ongoing assessment and revision of recruitment strategies is valuable; (2) a range of recruitment strategies may be useful; (3) the most effective methods for recruiting potential subjects may vary according to the gender, age, and race/ethnicity of those individuals; (4) recruitment strategies vary in the amount of staff time required to randomize a participant; and (5) a stepped screening may make it easier to identify and recruit volunteers who understand the requirements of the study.
AB - The Diabetes Prevention Program (DPP) is a multicenter randomized controlled trial designed to test whether diet and exercise or medication can prevent or delay the onset of type 2 diabetes in persons with impaired glucose tolerance, who are at increased risk of the disease. This paper describes DPP recruitment methods, strategies, performance, and costs. The DPP developed an organizational structure for comprehensive management and continuous monitoring of recruitment efforts. The DPP utilized a variety of recruitment strategies, alone or in combination, and a stepped informed consent procedure leading to randomization. Studywide and clinic-specific recruitment data were monitored, analyzed, and used to modify recruitment approaches. DPP recruitment was completed slightly ahead of schedule, meeting goals for the proportion of women enrolled and nearly meeting goals for the proportion of racial/ethnic minorities. Clinics varied widely in the recruitment strategies they used, and these strategies also varied by participant age, gender, and race/ethnicity. Staff time devoted to recruitment averaged 86.8 hours per week per clinic, with the majority of effort by staff specifically assigned to recruitment. The number of staff hours required to recruit a participant varied by recruitment strategy. Recruitment cost (excluding staff cost) was about US$1075 per randomized participant. The DPP experience offers lessons for those planning similar efforts: (1) a method for ongoing assessment and revision of recruitment strategies is valuable; (2) a range of recruitment strategies may be useful; (3) the most effective methods for recruiting potential subjects may vary according to the gender, age, and race/ethnicity of those individuals; (4) recruitment strategies vary in the amount of staff time required to randomize a participant; and (5) a stepped screening may make it easier to identify and recruit volunteers who understand the requirements of the study.
KW - Clinical trials
KW - Cost
KW - Diabetes prevention
KW - Participant recruitment
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UR - http://www.scopus.com/inward/citedby.url?scp=0036208902&partnerID=8YFLogxK
U2 - 10.1016/S0197-2456(01)00184-2
DO - 10.1016/S0197-2456(01)00184-2
M3 - Article
C2 - 11943442
AN - SCOPUS:0036208902
SN - 0197-2456
VL - 23
SP - 157
EP - 171
JO - Controlled Clinical Trials
JF - Controlled Clinical Trials
IS - 2
ER -