The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI...

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The Women’s Health Initiative Recruitment Methods and Results JENNIFER HAYS, PHD, JULIE R. HUNT, PHD, F. ALLAN HUBBELL, MD, MSPH, GARNET L. ANDERSON, PHD, MARIAN LIMACHER, MD, CATHERINE ALLEN, PHD, AND JACQUES E. ROSSOUW, MD Ann Epidemiol 2003;13:S18–S77. 2003 Elsevier Inc. All rights reserved. KEY WORDS: Clinical Trial, Cohort Study, Disease Prevention, Recruitment, Women’s Health, Postmenopausal Women. INTRODUCTION One of the most challenging aspects of the Women’s Health Initiative (WHI) was the recruitment of more than 161,000 women for this long-term prevention trial and observational study. The WHI had many enrollment goals that made recruitment efforts formidable (1). These included the recruitment of postmenopausal women, a group seldom tar- geted for clinical trials; enrolling minority groups in at least the same proportion as they existed in the general popula- tion; and enrolling women willing to participate in a long-term (8–12 year) study. The success of the WHI in meeting these goals can be attributed to several factors: the experience gained from prior studies, such as the National Cancer Institute (NCI)-sponsored Women’s Health Trial (2), the subsequent Women’s Health Trial Feasibility Study in Minority Populations (3), and the Postmenopausal Estro- gen/Progestin Interventions Trial (4); detailed planning by the WHI investigators; the dedication of recruiters, staff, and investigators at the clinical centers; and, a social and political climate that enhanced women’s interest in health research. Prior to the WHI, few large-scale prevention or clinical trials focused on postmenopausal women. Indeed, until re- cently, relatively little emphasis was placed on the recruit- ment of women of any age into such studies (5). However, during the last decade, a number of forces have come together to change this situation. The stance that women From the WHI Clinical Center, Baylor College of Medicine, Houston, TX (J.H.); Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA (J.R.H., G.L.A.); Department of Medicine, University of California at Irvine, Irvine, CA (A.H.); Department of Cardiology, University of Florida, Gainseville, FL (M.L.); Department of Preventive Medicine, University of Wisconsin-Madison, Madison, WI (C.A.); and WHI Project Office, National Heart Lung and Blood Institute, Bethesda, MD (J.E.R.) Address correspondence to: Jennifer Hayes, PhD, Baylor College of Medicine, Center for Women’s Health, 6535 Fannin, A701, Houston, TX 77030. Tel.: (713) 798-5770; Fax: (713) 798-5585; E-mail: [email protected] Received June 13, 2002; accepted February 14, 2003. 2003 Elsevier Inc. All rights reserved. 1047-2797/03/$–see front matter 360 Park Avenue South, New York, NY 10010 doi:10.1016/S1047-2797(03)00042-5 should be “protected” from biomedical research (6,7) has given way to the requirement that they be included so that more can be learned about their health care needs (8). Likewise, there have been increased efforts to recruit members of racial/ethnic minorities into clinical and pre- vention trials. The barriers that have limited the participa- tion of minorities in biomedical research have been reviewed in detail elsewhere (9–11). To ensure that the WHI findings would be as generalizable as possible to U.S. postmenopausal women, the study had to find ways to over- come these barriers and recruit a representative sample of minority women in this age group. This article reviews the WHI study population and screening process, recruitment methods, and the results of the recruitment efforts. We describe the common and unique strategies developed by individual clinics to enroll women in their local communities and the national framework that supported these efforts. The implications of the success of these methods for future studies are also discussed. STUDY POPULATION Eligibility was defined generally for all WHI components with component-specific exclusion criteria. All women en- rolled in the WHI were between 50 and 79 years old and were postmenopausal at the time of enrollment. Inclusion criteria were liberal in order to facilitate recruitment and enhance generalizability. In addition to age and menopausal status, eligibility criteria for the clinical trial (CT) and observational study (OS) included ability and willingness to provide written informed consent and an agreement to reside in the area for at least 3 years after enrollment. A partial factorial design enhanced the efficiency of re- cruitment by allowing women to enroll in the postmeno- pausal therapy (PHT) component, the dietary modification (DM) component, or both. The observational study cohort was comprised primarily of women screened for the clinical trial who were found to be ineligible or unwilling to be randomized to either the PHT or DM component, but

Transcript of The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI...

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The Women’s Health Initiative Recruitment Methods and Results

JENNIFER HAYS, PHD, JULIE R. HUNT, PHD, F. ALLAN HUBBELL, MD, MSPH,GARNET L. ANDERSON, PHD, MARIAN LIMACHER, MD, CATHERINE ALLEN, PHD,AND JACQUES E. ROSSOUW, MD

Ann Epidemiol 2003;13:S18–S77. � 2003 Elsevier Inc. All rights reserved.

KEY WORDS: Clinical Trial, Cohort Study, Disease Prevention, Recruitment, Women’s Health,Postmenopausal Women.

INTRODUCTION

One of the most challenging aspects of the Women’s HealthInitiative (WHI) was the recruitment of more than 161,000women for this long-term prevention trial and observationalstudy. The WHI had many enrollment goals that maderecruitment efforts formidable (1). These included therecruitment of postmenopausal women, a group seldom tar-geted for clinical trials; enrolling minority groups in at leastthe same proportion as they existed in the general popula-tion; and enrolling women willing to participate in along-term (8–12 year) study. The success of the WHI inmeeting these goals can be attributed to several factors: theexperience gained from prior studies, such as the NationalCancer Institute (NCI)-sponsored Women’s Health Trial(2), the subsequent Women’s Health Trial Feasibility Studyin Minority Populations (3), and the Postmenopausal Estro-gen/Progestin Interventions Trial (4); detailed planning bythe WHI investigators; the dedication of recruiters, staff,and investigators at the clinical centers; and, a social andpolitical climate that enhanced women’s interest inhealth research.

Prior to the WHI, few large-scale prevention or clinicaltrials focused on postmenopausal women. Indeed, until re-cently, relatively little emphasis was placed on the recruit-ment of women of any age into such studies (5). However,during the last decade, a number of forces have cometogether to change this situation. The stance that women

From the WHI Clinical Center, Baylor College of Medicine, Houston,TX (J.H.); Division of Public Health Sciences, Fred Hutchinson CancerResearch Center, Seattle, WA (J.R.H., G.L.A.); Department of Medicine,University of California at Irvine, Irvine, CA (A.H.); Department ofCardiology, University of Florida, Gainseville, FL (M.L.); Departmentof Preventive Medicine, University of Wisconsin-Madison, Madison, WI(C.A.); and WHI Project Office, National Heart Lung and Blood Institute,Bethesda, MD (J.E.R.)

Address correspondence to: Jennifer Hayes, PhD, Baylor College ofMedicine, Center for Women’s Health, 6535 Fannin, A701, Houston, TX77030. Tel.: (713) 798-5770; Fax: (713) 798-5585; E-mail: [email protected]

Received June 13, 2002; accepted February 14, 2003.

� 2003 Elsevier Inc. All rights reserved.360 Park Avenue South, New York, NY 10010

should be “protected” from biomedical research (6,7) hasgiven way to the requirement that they be included so thatmore can be learned about their health care needs (8).

Likewise, there have been increased efforts to recruitmembers of racial/ethnic minorities into clinical and pre-vention trials. The barriers that have limited the participa-tion of minorities in biomedical research have beenreviewed in detail elsewhere (9–11). To ensure that theWHI findings would be as generalizable as possible to U.S.postmenopausal women, the study had to find ways to over-come these barriers and recruit a representative sample ofminority women in this age group.

This article reviews the WHI study population andscreening process, recruitment methods, and the results ofthe recruitment efforts. We describe the common and uniquestrategies developed by individual clinics to enroll womenin their local communities and the national framework thatsupported these efforts. The implications of the success ofthese methods for future studies are also discussed.

STUDY POPULATION

Eligibility was defined generally for all WHI componentswith component-specific exclusion criteria. All women en-rolled in the WHI were between 50 and 79 years old andwere postmenopausal at the time of enrollment. Inclusioncriteria were liberal in order to facilitate recruitment andenhance generalizability. In addition to age and menopausalstatus, eligibility criteria for the clinical trial (CT) andobservational study (OS) included ability and willingnessto provide written informed consent and an agreement toreside in the area for at least 3 years after enrollment.

A partial factorial design enhanced the efficiency of re-cruitment by allowing women to enroll in the postmeno-pausal therapy (PHT) component, the dietary modification(DM) component, or both. The observational study cohortwas comprised primarily of women screened for the clinicaltrial who were found to be ineligible or unwilling to berandomized to either the PHT or DM component, but

1047-2797/03/$–see front matterdoi:10.1016/S1047-2797(03)00042-5

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were still interested in participating in a long-term researchstudy. Women enrolled in one of the clinical trial compo-nents were screened for eligibility and invited to join thecalcium and vitamin D (CaD) component at their first orsecond annual clinic visits.

Table 1 presents the specific exclusion criteria for thethree trial components and the OS. Eligibility was ascer-tained using a stepped approach. Most women were evalu-ated early in the process to minimize the screening effort andtime spent by ineligible women and clinic staff. Clinicalcenters were allowed to organize and schedule the requireddata collection procedures to fit their own logistical con-straints to improve efficiency. Thus, the order of data collec-tion varied between clinics and the proportions excludedby each reason has limited interpretation.

CLINICAL CENTERS

Participants were recruited from areas surrounding fortyclinical centers established primarily at major academichealth centers in 24 states and the District of Columbia.(See, the appendix in Rossouw’s article for a list of clinicalcenter locations.) Recruitment areas included urban, subur-ban, and rural populations. The original plan anticipated45 clinical centers, each of which was to enroll 1,267trial participants and 2,222 OS participants (total clinicaltrial � 57,000; OS � 100,000). Only 40 clinical centerswere ultimately funded, resulting in a need to enhancerecruitment through some of these existing sites. This addi-tional activity was supported contractually by giving centersthe option to supplement their recruitment goals in incre-ments of 25%. Sixteen clinical centers were formally ap-proved for enhanced recruitment. Others participatedinformally with more modest increases in recruitment ac-tivities.

Though not a probability sample, enrollment of racial/ethnic minority groups proportionate to the total minoritypopulation of women between 50 and 79 years of age (18.2%according to the 1990 U.S. Census) was a high priority ofthe program. To achieve this representation of minorities,10 (out of 40) clinical centers with expertise and access tospecific minority groups (American Indian, Black, AsianAmerican/Pacific Islander, Hispanic) were selected to serveas minority recruitment sites. These identified minority siteswere expected to have a 60% minority enrollment, whileother clinical centers were to enroll minorities in proportionto local demographics.

OVERVIEW OF THE RECRUITMENTAND SCREENING PROTOCOL

For most clinics, initial contact with potential participantswas through a mass mailing of the recruitment brochure,

which provided basic information on the WHI and con-tained a postage-paid return postcard to indicate interestin study participation. Trained telephone interviewers con-ducted additional eligibility screening with age-eligiblewomen who returned cards or called the clinical center. Atotal of three clinic visits were conducted to enroll womenin the clinical trial and at least one visit to enroll in theOS. Prior to the first screening visit, interested womenwere sent materials that included a cover letter, directions tothe clinic, a study logo bag for their current medicationsand dietary supplements, several self-administered question-naires, and instructions to prepare for a fasting blood draw.

At the beginning of the first screening visit, each womanwas given general information about the WHI componentsand viewed an introductory video providing an overviewof the study. An informed consent form was signed to coverinitial screening activities, including processing of question-naire data, drawing blood, and obtaining medical records.Questionnaires were briefly reviewed (including dietaryintake, behavioral measures, and medical, reproductive, andfamily histories) and brief physical examinations were con-ducted (anthropometric data). As the screening processcontinued, women received written materials and viewedvideos about the components they were interested in joiningand were asked to sign a consent form specific to each ofthese components. For those women progressing towardenrollment in the clinical trial, additional examinationsand procedures were conducted as needed (including breastexams, food records for the DM, and a pelvic exam withendometrial aspiration and a placebo run-in for the PHT).At the final screening visit, eligible women were randomizedby computer to intervention or control groups for each trialcomponent they were joining.

Women could be found to be ineligible or unwilling forclinical trial enrollment at any point in the screening pro-cess. These women were offered the opportunity to partici-pate in the OS and, if willing to join, completed OSenrollment activities at that time. In addition to thoseunable to join the clinical trial, several clinics recruitedspecifically for the OS toward the end of the recruitmentperiod. Throughout the screening process, women had theopportunity to discuss the study and the specific componentswith clinic staff and to ask related questions. A more thor-ough description of the flow of screening activities used torecruit participants has been published (12).

RECRUITMENT METHODS

Local Clinical Center Activities

The responsibility for recruitment rested in the hands ofthe individual clinical centers. Each was given the latitude to

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TABLE 1. WHI inclusion and exclusion criteria

Component Inclusion criteria Exclusion criteria

Clinical trial andobservational study 50–79 years of age

PostmenopausalIf age �55, no menstrual

period for at least 6 monthsIf age 50–54, no menstrual

period for at least 12 monthsAbility and willingness to provide

written informed consent(component specific)

Intention to reside in areafor at least 3 years

Clinical trial andobservational study Competing risk:

Any medical condition with predicted survival of �3 yAdherence or retention reasons:

Alcohol or drug dependencyMental illness, including severe depressionDementiaActive participation in other randomized intervention trial

Clinical trial Competing risk:Any invasive cancer in previous 10 yBreast cancer at any timeMammogram or CBE findings suspicious of breast cancerMI in previous 6 monthsStroke or TIA in past 6 monthsChronic hepatitis or severe cirrhosis

Safety reasons:Severe hypertension (systolic BP � 200 mm Hg or diastolic

BP � 105 mm Hg)Severely underweight (BMI �18 kg/m2)Hematocrit �32%Platelets �75,000 cells/mlCurrent use of oral daily corticosteroids

Adherence or retention reasons:Unwilling to participate in baseline or follow-up examination components

Dietary modification (DM) Adherence or retention reasons:Special dietary requirements incompatible with the intervention

(e.g., celiac sprue)On a diabetic or low salt dietGastrointestinal conditions contraindicating a high fiber dietType 1 diabetesColorectal cancer at any timeRoutinely eat �10 meals per week prepared out of the homeUnable to keep a 4-day food recordFFQ percent calories from fat �32%FFQ energy intakes �600 or �5000 kcalPrevious bilateral prophylactic mastectomy

Postmenopausal hormone therapy (PHT) Safety reasons:Endometrial cancer at any timeEndometrial hyperplasiaMalignant melanoma at any timeHistory of pulmonary embolism or deep vein thrombosisPrevious osteoporosis-related fracture being treated with hormonesHistory of bleeding disorder requiring transfusionHistory of hypertriglyceridemiaCurrently on anticoagulantsCurrently on tamoxifenAbnormalities in baseline pap smear, pelvic exam, or pelvic ultrasound

Adherence or retention reasons:Severe menopausal symptoms that would make placebo treatment

intolerableInadequate adherence to placebo run-inUnable or unwilling to discontinue use of PHT or testosteroneRefusal to have baseline endometrial aspiration

Calcium and vitamin D (CaD) Safety reasons:History of renal calculi or hypercalcemiaCurrent use of oral corticosteroids or calcitriolIntention to continue taking �600 IUs of vitamin D per day

BMI, body mass index; BP, blood pressure; CBE, clinical breast exam; FFQ, food frequency questionnaire; PHT, postmenopausal hormone therapy; TIA, transient ischemic attack.

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determine their own recruitment strategies, staffing patterns,clinic configuration, and visit flow. This level of flexibilitywas intended to allow each clinic to adapt the protocol tolocal strengths and constraints.

Staffing. Each center had a designated recruitment coor-dinator who served as the primary contact person withinthe study on recruitment-related issues. In most clinics,this person was responsible for local recruitment efforts,including mass mailings, community presentations, andmedia placement, but the training, scope, and level of re-sponsibility varied between sites. At some centers, thisperson served as a supervisor to telephone interviewers,managing some aspects of data collection. Leadership of therecruitment team was clinic-dependent. At some sites,the principal investigator actively participated in all recruit-ment efforts. At others, the clinic manager provided over-sight and direction, while the recruitment coordinatorsometimes had overall decision-making authority.

Recruitment staff were trained to offer a friendly, caring,and nonjudgmental dialogue with potential participants.Designated minority recruitment centers made efforts toassure that the staff, especially those involved in recruit-ment, were configured to reflect the population of inter-est. For those centers recruiting heavily in Hispaniccommunities, access to bilingual recruitment staff wasessential.

Local recruitment strategies. Most clinical centers inthe WHI used multiple recruitment strategies, with massmailings being the primary method of identifying interestedpotential participants for initial screening. The importanceof multiple methods and the effectiveness of mass mailingshave been documented in other studies that have recruitedolder adults to dietary and hormone therapy trials (13–16).Mass mailing represented the backbone of the WHI recruit-ment strategies because of its ability to reach the generalpopulation and its predictable load characteristics. Ad-dresses for mass mailings were obtained from a variety ofsources, including department of motor vehicle registrationlists, voter’s registration lists, driver’s license lists, HMOenrollee lists, Health Care and Financing Administration(currently known as the Centers for Medicare and MedicaidServices) lists, and commercial mailing lists of age-eligiblewomen. Many clinics also used enriched sources of potentialparticipants, such as those participating in or found to beineligible for previous clinical trials at their institutions.Most clinics (90%) used a professional mailing service tolabel, sort, and mail their brochures. Some used the brochureas a stand-alone mailer, while others added a cover letter,prescreening form, or interest survey.

Each clinic mailed an average of 1,000 to 5,000 brochuresper month over a 3- to 5-year period, with some mailing upto 50,000 brochures in each of the final months. Individualclinics determined the frequency and quantity of mailings,

which varied from weekly to quarterly, to maintain a steadyflow of screening visits. Response rates (i.e., the number ofwomen making contact for initial screening) varied acrossclinics and sources of mailing lists from less than 2% toapproximately 20% for initial mailings, with somewhat low-er rates for repeat mailings. Most centers repeated mailingsto the same area several times (2–7 mailings to the samepopulation) over the period of recruitment.

Mailings were supplemented by the following publicawareness and recruitment strategies:

Community presentationsLocal newspaper articlesNewspaper adsPublic service announcements (television and radio)Name-a-friend programs, soliciting referrals from

enrolled participantsIncentives (small gifts)Health fairsNational and local press releasesPhysician/health care provider referralsBrochure placement in community (e.g., pharmacies,

supermarkets, beauty salons, churches)Alliance building (meeting with women’s groups such

as sororities)Establishing community advisory boards for recruitment,

brainstorming, contactsMailings to physicians to request referrals

The strategies employed varied from site to site. Someof the more unusual strategies included providing transpor-tation to screening visits, enlisting the support of local cele-brities, and flying an airplane pulling a WHI recruitmentadvertisement over a college football game. Not all strategieswere equally effective, and no formal evaluations of theseefforts were conducted on a study-wide basis. Nevertheless,anecdotal information may be illuminating. For example,most recruitment coordinators reported that asking physi-cians to make referrals yielded few or no referrals. However,many investigators believed that it was important to contactprimary care physicians in the community to enlist theirsupport of their patients’ participation in the study. Mostclinical centers felt it was important to increase the women’sawareness of the study. They did this through the media(e.g., paid advertisements, public service announcements,feature stories, and interviews) and by speaking at localwomen’s events. Women were not paid to participate inthe study, but a few clinics provided small incentives (e.g.,refrigerator magnet photo frames with the WHI logo) atenrollment and follow-up visits. Women who were enrolledwere encouraged to “enroll a friend” to help spread themessage in hard-to-reach populations.

Strategies used to recruit members of minority groupsincluded presenting information at churches, social gather-ings, and organizations frequented by members of these

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groups, or meeting with tribal leaders to gain access toAmerican Indian women. Emphasis was also placed on con-tacting organizations for seniors and placing ads and bro-chures in places most visible to the target age group.Accommodations were made to ensure that materials andvisits were appropriate for the target populations, such asallowing extra time at screening visits, providing extraassistance for women with physical limitations, and usinglarge-size print for all written materials. Many clinics createdlocal advisory boards to generate support from the localcommunity and provide a ready source of feedback for na-tionally and locally created recruitment materials.

The WHI did not mandate adherence to one recruitmenttechnique, but rather allowed each clinic to determine thebest ways to maximize results in their own communitieswith their own resources and ideas. Clinics also made inde-pendent decisions about clinic hours and locations. Someclinics were open on Saturdays, while others were openduring at least one evening per week to accommodatewomen who worked during weekday hours.

Clinics made efforts to help women overcome obstaclesto participation, including helping to create carpools andproviding bus passes, providing child care for women withprimary responsibility for grandchildren, and reimbursingwomen for all or part of their parking fees. To make partici-pation easier for relatives, women living in the same house-hold, or those living close to one another, clinical centerswere allowed to randomize groups of two or more partici-pants together to a study arm. This was to help overcometransportation difficulties and to make sure that womenliving in the same household were not randomized to differ-ent arms in the DM. Overall, 456 groups of two or morewomen were formed (the maximum number of women ran-domized together was four), resulting in a total of 941 DMparticipants selecting this option.

Clinics routinely called to remind participants of sched-uled appointments, and follow-up calls were made if ap-pointments were missed. Logs were maintained of allcontacts and outcomes. Regular strategy meetings were heldto review outcomes from previous activities and makeadjustments or take new directions. Although much effortwas placed on meeting recruitment goals, the long-termnature of the WHI and the expectation for active studyparticipation made it very important to recruit women whowould be likely to stay with the study through the endof the intervention and follow-up period. The ambitiousrecruitment goals and the need to enroll women withoutsubstantial barriers to long-term adherence created a naturaltension within the clinics. This was addressed with varyinglevels of success across clinics, but was most effectivelymanaged in clinics where there was active leadership inplace from someone with broad responsibility for the successof the overall program.

Activities at the National Level

Numerous activities at the national level supported andmonitored local clinic efforts and enhanced visibility andbonding study-wide. These efforts, provided by the NationalInstitutes of Health (NIH), the Clinical CoordinatingCenter (CCC), the Clinical Facilitation Center (CFC, sub-contractor to the CCC for many aspects of performancemonitoring), and various study-wide committees, includedcentrally produced recruitment and screening materials,central training workshops and support for local recruitmentstaff, a national public awareness campaign, a toll-free re-cruitment telephone line, and input from advisory groupswith expertise in select areas.

Central development of materials. Recruitment materi-als were developed and produced centrally for study-wideuse at the local level. These materials included a recruitmentbrochure with a postage-paid postcard customized for eachclinic; a consent video providing an overview of study re-quirements shown at initial screening visits; a recruitmentvideo featuring interviews with study participants; screen-ing, eligibility, and consent forms; and recruitment posters,flyers, and postcards. All study-wide recruitment materialsincluded the WHI logo (a stylized depiction of the profiles ofthree womens’ faces and the study title), the study colors(dark blue and bright purple), the toll-free telephonenumber, and the catch phrase (“Be part of the answer”) toenhance visibility and identification of the study. Most ofthe printed materials could be customized and supplementedwith local information.

Spanish versions of all recruitment materials, includingthe videos and study logo, were available. Women of variousethnic backgrounds were included in videos, posters, andbrochures. Special materials were developed to address spe-cific study needs as they arose. For example, when recruit-ment goals for the younger age groups and the DM trialwere met, special recruitment materials were developed spe-cifically for the PHT and CaD trials targeting women overage 65. These included component-specific brochures anda letter from the director of the NIH.

Central training and support of local staff. Standardscreening, consent, and eligibility procedures were devel-oped at the national level and used across all clinics. Study-wide workshops were held annually for lead clinic recruit-ment staff during the recruitment period. These sessionsprovided the staff with an opportunity to share recruitmentprocedures and strategies and ensure that eligibility andscreening procedures were consistent across clinics.

A full-time clinic recruitment staff liaison at the CCCprovided general support for clinic recruitment activities bypreparing recruitment progress reports, distributing materi-als and media placement information, assisting with ob-taining mailing lists from the Health Care and Financing

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Administration, and serving as a daily resource. Clinics hadaccess to study-wide networking and support via monthlyregional and national conference calls with recruitment stafffrom other clinics and the CCC recruitment liaison. Thepurpose of these calls was to disseminate information,share successful recruitment strategies, review recruitmentprogress reports, and provide moral support and encourage-ment. The WHI wide-area network provided a forum forongoing e-mail communication and the dissemination ofrecruitment tips, strategies, and study updates in the formof a biweekly recruitment staff newsletter.

National public awareness campaign. During thesecond year of recruitment, a national public relations firm(Porter-Novelli) was enlisted to enhance study visibilityand aid with national media placement and materials devel-opment. Over the course of 3 years, the firm developedEnglish and Spanish print, radio, and television public ser-vice announcements (PSAs); distributed PSAs to nationalmedia outlets, resulting in placements in several widelycirculated national magazines; assisted in the developmentof recruitment brochures, posters, and “invite a friend”postcards; produced consent and recruitment videos; distrib-uted press kits and instructions to clinics for local mediaplacement; and enlisted well-known celebrities (e.g.,Angela Lansbury, Geraldine Ferraro) to serve as spokesper-sons and appear in recruitment materials. They also con-ducted focus groups and surveys of older women,incorporating these findings into materials and strategies.Altruism and the genuine desire to help other womenseemed to be a theme that women identified with, sincethey understood that while study participation might notbenefit them directly, the results would be helpful to futuregenerations. This need to help other women and developanswers to women’s health questions was reinforced in re-cruitment materials. The catch phrase “Be part of theanswer” emphasized the idea that participants would be animportant part of a group of women working together tofind the answers to health questions facing all women.

Recruitment telephone line. A national toll-free tele-phone recruitment line (1-800-54-WOMEN) was estab-lished and maintained throughout the recruitment period.Women calling the number were automatically linked tothe clinic nearest them. The CCC support person main-tained the telephone line by collecting area code routinginformation from clinics. Women living outside of clinicalcenter catchment areas were routed to the CCC and re-ceived a letter thanking them for their interest and abrochure listing the clinics and their locations.

Advisory groups. Early in the recruitment period, sev-eral committees comprised of WHI Investigators and staffmembers with specific expertise in areas such as specialpopulations, clinic operations, and recruitment were formed.These committees were charged with identifying potential

national recruitment efforts, reviewing all strategies andstudy materials, providing input on local recruitment strate-gies, managing the related clinical and operational aspectsof recruitment, and providing recommendations toward in-creasing minority enrollment, including issues of culturalsensitivity.

Recruitment Monitoring

Recruitment progress was monitored centrally and locallythroughout the recruitment period. To monitor overall re-cruitment progress and individual clinic performance, theCCC generated and distributed monthly reports depictingthe expected and actual cumulative enrollment by studycomponent in a graphical format (Figure 1). The CCC alsoprovided graphical reports showing enrollment by age, andby uterus status (for PHT trial), as well as detailed tabulardata of monthly and cumulative enrollment by age and race/ethnicity for each of the study components, for each clinic,and for all clinics combined. These reports identified recruit-ment deficits as they arose, so that special efforts couldbe made to achieve goals for all components, age, and racial/ethnic groups.

A Performance Monitoring Committee (PMC), con-sisting of representatives from the CCC, the CFC, the NIH,and the clinical centers, monitored recruitment progressthroughout the enrollment period. The PMC reviewed eachclinic several times per year to assess the clinic’s progressin reaching their overall goals, as well as those for the agecategories, study components, and minority groups.

Clinical centers that did not meet their goal after areasonable interval were provided with varying levels ofguidance and intervention to assist the center in achievinggoals. A recruitment spreadsheet and associated catch-upplan was developed and provided to each clinic. This toolallowed them to estimate the level of mailings required toachieve their goals based on the clinic-specific recruitmentrecord to date and other local level parameters such as stage-specific yields. For centers experiencing continuing difficult-ies in meeting recruitment goals, the PMC conducted con-ference calls and, in some cases, team visits to assess thelocal efforts and provide guidance. These were followed upwith written reports that included specific action plans. Aconsistent theme in these interactions was the need toestablish a mass-mailing program with adequate trackingto estimate yields, and to feed this information back intothe mailing program.

Recruitment Data Collection

Most clinics used a tracking system to calculate the yieldsfrom their mailings and other recruitment efforts, but thetypes of system and information tracked varied widely acrosssites. No study-wide system was implemented because of

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FIGURE 1. Projected and actual recruitment into WHI.

the clinic interests in maintaining as much local flexibilityas possible. Therefore, total mailing numbers and responserates from mailings are not available across clinics. In addi-tion, because each site could organize the screening processaround their own strengths and constraints, the interpreta-tion of step-by-step yields is not meaningful across sites.However, estimates of the yields from initial mailings andscreening visits could be made for each center individually,based on their own mailing and enrollment numbers duringthe early months of recruitment. Using this information,clinics projected the number of mailings and screening visitsneeded per month to meet their specific goals by the end of

the recruitment period. Based on overall estimates providedby clinics, approximately 3.2% of the recruitment mailingsresulted in a contact with a potential participant to conductinitial screening activities.

In the context of initial screening, either by telephoneor a self-administered questionnaire, potential participantswere asked how they heard about the study and asked toselect from one of the following: mailed letter/brochure, TV,radio, newspaper/magazine, meeting, friend/relative, other.These data were collected for all women screened, but clinicswere not required to enter information for women who weredetermined to be clearly ineligible. Therefore, the total

TABLE 2. Study component recruitment by age and ethnicity

Completed Randomized Enrolledscreening form to clinical trial Percentage in observational Percentage(N � 373,092) (N � 68,133) of screened study (N � 93,676) of screened

Age at screening�50 96150–54 52,539 9,190 17.5 12,386 23.655–59 71,347 14,663 20.6 17,319 24.360–69 159,321 31,390 19.7 41,197 25.970–79 88,280 12,890 14.6 22,774 25.8�79 100Missing 544

Race/ethnicityAmerican Indian 1,909 293 15.4 422 22.1Asian 8,954 1,521 17.0 2,671 29.8Black 34,578 6,988 20.2 7,639 22.1Hispanic 15,116 2,889 19.1 3,623 24.0White 300,445 55,521 18.5 78,013 26.0Unknown 12,090 921 7.6 1,308 10.8

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number of women screened for the WHI is not known, andtotal yields of each method based on the number screened areoverestimated; however, because most women aged 50 to79 were eligible for the OS, most clinics routinely enteredthese data.

RESULTS

The number of women with WHI screening data and theproportion of those randomized or enrolled in the clinicaltrial and OS by age and ethnic group are provided in Table2. A total of 373,092 women completed the initial screeningform. Of those, 68,133 (18%) went through the subsequentscreening visits to be randomized into the clinical trial, and93,676 (25%) were enrolled in the OS. Women in the oldestage group (70–79 years of age) had the lowest proportion ofwomen randomized to the clinical trial after completinginitial screening. There was little variability across agegroups in the proportion of those screened that enrolled inOS. There was little racial variability in the proportion ofwomen who were randomized to the clinical trial after com-pleting an initial screening form, with 20% of Black, 19%of Hispanic, and 18% of Caucasian women completing therandomization process. Asian women (30%) were the mostlikely to be enrolled in the OS after entering the screen-ing process.

Source of Information about WHI

Table 3 shows the reasons for initial contact with the WHIby enrollment status, and the age, race, and regional break-downs for women who were enrolled or randomized in oneof the study components. The majority of women (66.7%overall) indicated that they heard about the WHI througha mailed letter or brochure. Reading about the WHI in apaper or magazine was the next most common source ofinformation about WHI (14.0% overall), followed by hear-ing about the study from a friend or relative (8.3%). Therewere no major differences between women who enrolled inthe clinical trial versus the OS versus those who were notenrolled in either component.

There were several variations in sources of informationabout WHI by age group, race, and region. While a mailedletter or brochure was the most frequent response for allage groups, a higher percentage of women in the 70–79category (70.3%) selected this source of information com-pared with women in the younger age groups (65.3% forthose 60–69 and 55.1% for those 50–59). Women in theyoungest age group were more likely to mention a TV orradio advertisement than were women in the two olderage groups.

The media selected most often by women of all racialbackgrounds was a mailed letter/brochure, while the second

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S26 Hays et al.THE WHI RECRUITMENT METHODS AND RESULTS

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TABLE 4. Reasons for exclusion from WHI studycomponentsa

Percentage ofComponent Criterion for exclusion total ineligibleb

PHT No consent/not interested in PHT 81.2Clinic impression of ineligibility 4.8Stratum full or closed 4.6History of breast cancer 4.5

DM No consent/not interested in DM 50.3FFQ percent calories from fat/energy 41.9

intakesStratum full or closed 11.010� meals away from home per week 5.3History of breast cancer 4.8

CaD Not willing to limit use of vitamin D 73.0No consent/not interested in CaD 44.3History of kidney stones 13.1Clinic impression of ineligibility 5.8

OS No consent/not interested in OS 76.6Stratum full or closed 9.9

CaD, calcium and vitamin D; DM, dietary modification; FFQ, food frequency ques-tionnaire; OS, observational study; PHT, postmenopausal hormone therapy.aOnly includes reasons with �4% of total ineligible.bA participant may be ineligible for more than one reason.

most frequent category varied. There were also slight re-gional variations in the source of information cited.Because each site determined their own mix of recruitmentefforts based on their judgment of the potential effectivenessof the methods in the local population, this variation is afunction of both the choice of approaches used in thesepopulations as well as their effectiveness.

The age, race, and regional variations in reasons forcontacting the WHI for the sample of women who ulti-mately enrolled in the clinical trial or OS were similar towomen who were screened for, but did not join, the WHI(data not shown).

Reasons for Exclusion from Study Components

Table 4 presents the most common reasons for exclusionfrom each of the study components for women withscreening data. For all components, lack of interest and/or signed consent was the primary reason women did notjoin that particular part of the study (50.3% for DM, 81.2%for PHT, and 76.6% for OS). For DM, almost 42% wereineligible based on initial dietary assessment; about 10% ofwomen screened were ineligible for DM due to competingrisk and fewer than 3% were ineligible for safety reasons.For PHT, ineligibility due to competing risk factors overallwas around 10%; exclusion for safety reasons overall wasalso about 10%.

There are limitations to these data, including the factthat screening data were not entered for all women deter-mined to be ineligible during initial screening. For those

that were entered, further eligibility data were not collectedonce a woman was determined to be ineligible for a particu-lar component; criteria screened late in the process aretherefore lower than they might have been had they beenscreened at an earlier stage. Because there were variationsacross clinics in the timing of screening activities, theserates are an approximation.

Characteristics of the Recruited Population

Table 5 presents the demographic and personal characteris-tics of women who enrolled in each component of the WHI.The final clinical trial enrollment was 27,347 for PHT (99%of the goal), 48,836 for DM (102% of the goal), and 36,282for CaD (81% of the goal); final enrollment in the OS was93,676 (94% of the goal). Randomization goals were metor exceeded for each of the age categories in both the PHTand DM arms of the clinical trial with the exception of the70–79 age group, which proved to be the most challengingrecruitment task.

Minority women were recruited into the clinical trial inthe same proportion (18.5%) as is found in the U.S. popula-tion (18.2%) for a total of 12,612 minority women. The OSfell short of the 18.2% goal by less than two percentagepoints (16.7%, n � 15,663). Except for Hispanics, propor-tional representation of minority groups (Black, AmericanIndian, Asian/Pacific Islander) was close to the nationaldistribution. On average, designated minority clinics en-rolled 40% minorities, while nonminority clinics enrolledan average of 10%. Extensive descriptions of all CT and OScohorts by race/ethnicity are provided in the appendix atthe end of this article.

Approximately one third of women in the WHI have atleast a college degree, with an additional 36–40% havingsome education after high school. Minority women wereleast likely to hold a college degree and most likely tohave attended only 0–8 years of school (data shown inappendix at the end of this article). Income was lowest forthe PHT sample and highest for women in the OS. Amajority of women in all components were married or livingas married at the time of enrollment, while nearly one thirdwere divorced/separated or widowed.

Women in the WHI were more likely to be overweight orobese than normal or underweight at the time of enrollment.Based on a body mass index of 25 or greater, three quartersof the women in the clinical trial were overweight or obese,as were nearly 60% of women in the OS. More than 90%of women in each component, however, rated their currenthealth as good or better.

Recruitment efforts were enhanced through the use of apartial factorial design allowing women to enroll in morethan one of the clinical trial components. Overall, 53.3%of women in the clinical trial were enrolled in CaD,

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TABLE 5. Baseline characteristics of WHI final enrollment participants

PHT DM CaD OSN � 27,347 N � 48,836 N � 36,282 N � 93,676

N % N % N % N %

Age at screening (y)50–54 3425 12.5 6958 14.2 5157 14.2 12,386 13.255–59 5402 19.8 11,041 22.6 8264 22.8 17,319 18.560–69 12,364 45.2 22,714 46.5 16,521 45.5 41,197 44.070–79 6156 22.5 8123 16.6 6340 17.5 22,774 24.3

Race/ethnicityAmerican Indian 131 0.5 203 0.4 149 0.4 422 0.5Asian/Pacific Islander 527 1.9 1107 2.3 722 2.0 2671 2.9Black 2741 10.0 5266 10.8 3317 9.1 7639 8.2Hispanic 1543 5.6 1854 3.8 1507 4.2 3623 3.9White 22,027 80.5 39,760 81.4 30,153 83.1 78,013 83.3Unknown 378 1.4 646 1.3 434 1.2 1308 1.4

Education0–8 years 708 2.6 576 1.2 527 1.5 1560 1.7Some high school 1459 5.4 1639 3.4 1375 3.8 3288 3.5High school diploma/GED 5643 20.8 8518 17.6 6673 18.5 15,121 16.3School after high school 11,036 40.7 19,308 39.8 14,372 39.9 33,933 36.5College degree or higher 8296 30.6 18,488 38.1 13,098 36.3 39,002 42.0

Family income�$10,000 1721 6.7 1783 3.9 1465 4.3 3916 4.5$10,000–$19,999 4337 16.8 5294 11.5 4353 12.6 10,100 11.7$20,000–$34,999 7315 28.3 11,315 24.6 8911 25.9 20,226 23.3$35,000–$49,999 5276 20.4 9822 21.3 7302 21.2 17,429 20.1$50,000–$74,999 4220 16.3 9549 20.8 6849 19.9 17,486 20.2$75,000� 2941 11.4 8242 17.9 5546 16.1 17,608 20.3

Marital statusNever married 1023 3.8 1970 4.1 1437 4.0 4390 4.7Divorced/Separated 4812 17.7 7704 15.8 5724 15.8 14,727 15.8Widowed 5453 20.0 7646 15.7 6012 16.6 16,290 17.5Presently married/Living as married 15,929 58.5 31,293 64.4 22,962 63.5 57,805 62.0

Body mass index (BMI), kg/m2

Underweight (�18.5) 157 0.6 154 0.3 148 0.4 1107 1.2Normal (18.5–24.9) 7107 26.1 12,503 25.7 9430 26.1 36,687 39.6Overweight (25.0–29.9) 9533 35.1 17,387 35.8 12,955 35.9 31,463 34.0Obesity I (30.0–34.9) 6183 22.7 11,198 23.0 8203 22.7 14,578 15.8Obesity II (35.0–39.9) 2807 10.3 5048 10.4 3644 10.1 5451 5.9Obesity III (�40) 1405 5.2 2322 4.8 1715 4.8 3282 3.6

Perceived health statusExcellent 4314 15.9 7616 15.7 6274 17.4 16,577 17.8Very good 11,197 41.2 19,968 41.1 15,482 42.9 37,686 40.5Good 9234 34.0 17,081 35.2 11,942 33.1 29,670 31.9Fair 2259 8.3 3675 7.6 2271 63.3 8210 8.8Poor 155 0.6 240 0.5 125 0.3 882 1.0

CaD, calcium and vitamin D; DM, dietary modification; OS, observational study; PHT, postmenopausal hormone therapy.

11.8% were enrolled in both DM and PHT, and 7.4% ofclinical trial participants were enrolled in all three trials(data not shown). Table 6 displays the percent overlapacross the three clinical trials. Nearly 30% of PHT partici-pants were also in the DM and close to 59% were in CaD.In the DM trial, 16.5% were also in PHT and just over50% were in CaD.

DISCUSSION

The WHI met recruitment goals, including reaching a di-verse population of postmenopausal women. The recruit-ment experience of the WHI may provide several usefullessons for investigators undertaking randomized clinicaltrials with older women.

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At the clinic level, several factors may have contributedto successful recruitment. First, making the clinic as accessi-ble as possible to older women was crucial. For many clinics,this involved staffing a satellite clinic part- or full-time andproviding parking and/or reimbursement for transportationcosts. Having convenient clinic hours was also perceivedto be important, as was making sure that the clinic waswell-managed and staffed by competent and friendly staffmembers. Second, weekly monitoring of clinic recruitmentgoals was necessary, including close review of reports distrib-uted from the CCC and yields from mailings and otherrecruitment activities. Third, while multiple recruitmentmethods were employed, the use of mass mailings was criticalto reach the large numbers of women needed for WHI.Although most clinics tried other strategies, in the longrun, all clinics relied on mass mailings as their primaryrecruitment method.

In addition to frequent internal and external monitoring,sharing recruitment strategies among and between clinicswas also helpful. Although clinics often differed in thecharacteristics and responses of potential participants intheir areas, many strategies were useful across regions andclinics. A recruitment brochure that targeted the PHT armof the trial, for example, proved to elicit a good responserate in one clinic, and was shared on the monthly calls andfrequent e-mails between recruitment coordinators in thelocal clinics and with liaison staff at the CCC. In addition,the second group of clinical centers was able to learn fromthe experience of the vanguard group, which had startedrecruiting 18 months earlier. When the second round ofclinical centers was funded, they were assigned a vanguardcenter to provide advice and assistance to help them “rampup” quickly to the recruitment task.

One of the potentially overlooked reasons for the WHI’ssuccessful recruitment was the women’s awareness of theneed for this research and their eagerness to participate. Par-ticipants repeatedly mentioned that they did not feel enoughwas known about women’s health. Many of them experi-enced a need for answers to their own health questions(e.g., whether or not to take hormones), and they wantedtheir daughters and granddaughters to be better informed inthe future.

All WHI materials were printed with the WHI logo usingthe WHI colors. Marketing experts commonly refer to thisas branding, the development of an easily identifiable imageassociated with a product or service. The consistent use ofvisual images and verbal messages helped to create a WHIbrand that was easily recognizable. The use of multiple andvaried channels to communicate the WHI recruitmentmessage helped participants identify with the idea thatthey were “part of the answer” to questions aboutwomen’s health.

TABLE 6. WHI clinical trials: percent overlap betweencomponents

In all threeComponent N PHT DM CaD components

PHT 27,347 100% 29.4% 58.8% 18.4%DM 48,836 16.5% 100% 51.6% 10.3%CaD 36,282 44.3% 69.5% 100% 13.8%Total CT 68,133

The partial factorial design allowed a large cost savingsince there was overlap in many of the study procedures forthe three trials. Women who were unwilling or ineligiblefor the clinical trial were invited to participate in the OS,which allowed this additional resource to be developed atvery modest additional cost. In addition, the packaging ofthese components into one large program brought attentionto the effort.

Not all efforts and clinics achieved equal success. Becausethe focus of study was not on the comparison of variousrecruitment strategies, it is not known whether the differ-ences in recruitment success among the 40 clinics is due toclinic characteristics, their various recruitment strategies,or the unique characteristics of the clinic’s community andregion. Clinics varied on a multitude of categories, includ-ing sociodemographic characteristics of participants; urban,rural, or suburban settings; ethnic and minority makeup ofparticipants; and the experience of the clinic in conductinglarge trials. Women differed by clinic and region on ratesof exclusion. For example, women were more likely to al-ready be on hormones in some regions, making them lesslikely to be interested in that arm of the study (whichinvolved a 3-month wash-out, with only a 50% chance ofbeing put on active hormones again). Women of someethnic groups were less likely to be interested in the DMbecause of their own cultural dietary practices, while otherswere already following low-fat diets and were thereforeineligible.

The WHI encountered several challenges during the re-cruitment process, many of which were addressed on boththe study-wide and local level. Early on, it became apparentthat OS enrollment was exceeding that for the clinical trial,prompting a temporary hold on OS enrollment. Projectionsof end numbers for each trial component by age stratumnecessitated early closure of younger age cells that werelikely to become overrepresented and focused clinic effortson the older age groups and the PHT trial component.For example, toward the end of recruitment, clinics usedenriched mailing lists (such as Medicare lists) and placedstories in magazines with an older audience to target olderwomen. To help compensate for lower accrual rates inthe PHT trials, PHT-only mailings were used, especially

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in areas with low current hormone use, and clinic staffmembers were encouraged to spend more time briefing po-tential PHT participants before asking them to make adecision.

Minority recruitment was somewhat more difficult andcostly than anticipated for several reasons. Because minoritywomen often have lower income levels, they may face moreobstacles to participation than middle-class majoritywomen. For example, minority women may have transpor-tation difficulties, be caregivers for grandchildren or otherfamily members, move more frequently, or have interruptedtelephone service. If they are living at or below the povertylevel, they may experience additional stresses and be lessinclined to give their time and efforts for research pur-poses. Minority women may be less familiar with the medicalestablishment and the idea of research volunteerism, or theymay be suspicious of the research process.

To meet the special challenges in recruiting women fromminority populations, designated minority clinics were se-lected in geographic areas with large minority populations.Clinics that enrolled large proportions of minority partici-pants required an average of 2.5 more staff members thanthe remaining clinics. The average staffing level across thestudy was approximately 15 full-time equivalents for a clinicenrolling 1,700 clinical trial participants and 2,200 OS par-ticipants. Overall, WHI clinics used about 0.5 additionalstaff/100 participants for every 10% minority participantsenrolled. In addition, mailing volumes and costs were higherin minority clinics. Incentives were offered to clinics tocompensate for additional effort needed to succeed in minor-ity enrollment, and enrollment of minorities was extendedby 6 months for the OS.

All clinics found it to be more difficult to recruit womenin the 70–79 year age group than those in the younger agegroups. Many of the issues facing minority participants alsoaffected women in the older age groups because womentend to have less income and more obstacles to participatingin research studies as they age. Women in the oldest agecategory were more likely to have health problems thatlimited either their eligibility or their ability to participate,to have transportation or other mobility problems, or tofeel that they were too old to be of value to the study.Successful efforts to recruit older women included obtainingmailing lists of older women, contacting retirement andother groups with a high proportion of older members,and asking older women to recommend a friend. In addition,a campaign specifically targeting older women, including aspecial invitational letter to join the WHI from the directorof the NIH, was conducted toward the latter part of therecruitment period.

Finally, recruitment for the CaD trial, into which partici-pants were enrolled at their 1- or 2-year annual visit, provedmore difficult than originally envisioned. Reasons for thisincluded a feeling they were doing enough for WHI already;a reluctance to take an additional pill (for those in thePHT); an unwillingness to take pills (mostly DM partici-pants) and/or reluctance to taking additional supplements(for those already taking supplements); and the perceptionthat the CaD trial was not as exciting as the other two trials.To address these difficulties, additional emphasis was madeto clinic staff regarding the importance of this component,a special CaD recruitment brochure was developed, andparticipants were given a second opportunity to join at thesecond annual clinic visit, resulting in an improvement inrecruitment rates.

SUMMARY

The recruitment of women into the WHI stands as animportant accomplishment in clinical research history. Thisstudy demonstrated that postmenopausal women of variedethnic groups could be recruited in large numbers acrossthe U.S. More than 161,000 enrolled in one or more compo-nents of the study. The complex study design included threenested clinical trials and an observational study, and allowedeach woman to choose how she participated, from takingstudy pills to enrolling in a dietary modification programto participating at an observational level only. Study partici-pation required at least a 3-year commitment of all par-ticipants, and participants are urged to stay with the studyfor the full follow-up period of 8–10 years. Multiple, intense,and overlapping recruitment strategies at the national andlocal levels were essential for achieving the recruitmentgoals of the study. Recruitment also required significantcommitments of financial and personnel resources. Severalstrategies proved indispensable, especially mass and repeatedmailings to potential participants. Other strategies wereused to recruit older women and women from a variety ofracial and ethnic groups. Many of the strategies developedand used in this study are applicable for future preventiontrials.

APPENDIX: COMPREHENSIVE DISPLAYOF INFORMATION BY RACE AND ETHNICITYFOR THE CLINICAL TRIAL ANDOBSERVATIONAL STUDY

Tables 1–20

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Page 14: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

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Page 16: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

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Page 17: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

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Page 18: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

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itho

utm

iner

als)

No

135

66.5

732

66.1

4070

77.3

1371

73.9

24,7

5662

.331

,497

64.5

Yes

6833

.537

533

.911

9622

.748

326

.115

,003

37.7

17,3

3835

.5V

itam

inC

assi

ngle

supp

lem

ent

No

158

77.8

819

74.0

4433

84.2

1512

81.6

30,0

8475

.737

,503

76.8

Yes

4522

.228

826

.083

315

.834

218

.496

7624

.311

,333

23.2

Vit

amin

Eas

sing

lesu

pple

men

tN

o15

877

.878

470

.844

4784

.414

6879

.229

,099

73.2

36,4

4774

.6Y

es45

22.2

323

29.2

819

15.6

386

20.8

10,6

6126

.812

,389

25.4

Cal

cium

assi

ngle

supp

lem

ent

(inc

ludi

ngan

taci

ds)

No

160

78.8

803

72.5

4672

88.7

1516

81.8

29,4

1274

.037

,074

75.9

Yes

4321

.230

427

.559

411

.333

818

.210

,348

26.0

11,7

6224

.1Si

ngle

supp

lem

ent

(not

Vit

amin

C,E

,or

calc

ium

)N

o13

566

.566

660

.240

0276

.013

1971

.125

,658

64.5

32,1

9865

.9Y

es68

33.5

441

39.8

1264

24.0

535

28.9

14,1

0235

.516

,638

34.1

Any

supp

lem

ent

(exc

ludi

ngsi

ngle

supp

lem

ent

calc

ium

)N

o85

41.9

383

34.6

2883

54.7

918

49.5

15,0

2337

.819

,558

40.0

Yes

118

58.1

724

65.4

2383

45.3

936

50.5

24,7

3762

.229

,278

60.0

a Tot

alin

clud

esth

ose

ofun

know

net

hnic

ity.

*Dat

aw

ithh

eld

from

cells

whe

reN

�5

(�10

whe

reda

taar

ese

nsit

ive)

.

Page 19: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

AP

PE

ND

IXT

AB

LE

4.B

asel

ine

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ogra

phic

and

gene

ral

heal

thch

arac

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sof

WH

IC

alci

uman

dV

itam

inD

part

icip

ants

byra

ce/e

thni

city

Rac

e/Et

hnic

ity

Am

eric

anIn

dian

Asi

an/P

acifi

cB

lack

His

pani

cW

hite

Tot

ala

(N�

149)

Isla

nder

(N�

722)

(N�

3317

)(N

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07)

(N�

30,1

53)

(N�

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82)

Cha

ract

eris

tic

N%

Mea

n�

SDN

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ean

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N%

Mea

n�

SDN

%M

ean

�SD

N%

Mea

n�

SDN

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ean

�SD

Age

atsc

reen

ing

(y)

149

61.5

�6.

772

261

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7.1

3317

60.6

�6.

815

0759

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6.4

30,1

5362

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6.9

36,2

8262

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7.0

50–5

961

40.9

309

42.8

1572

47.4

844

56.0

10,4

6934

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37.0

60–6

968

45.6

301

41.7

1354

40.8

546

36.2

14,0

5746

.616

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70–7

920

13.4

112

15.5

391

11.8

117

7.8

5627

18.7

6340

17.5

Educ

atio

n0–

8y

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917

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652

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me

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scho

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689

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013

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8H

igh

scho

oldi

plom

a/G

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105

14.7

476

14.5

273

18.4

5713

19.1

6673

18.5

Scho

olaf

ter

high

scho

ol72

48.6

267

37.3

1389

42.4

538

36.2

11,9

2139

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39.9

Col

lege

degr

eeor

high

er37

25.0

315

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1064

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272

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Fam

ilyin

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999

3020

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999

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5,00

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9,99

929

20.0

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19.2

586

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215

15.7

6250

21.8

7302

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3020

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ial/P

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5238

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3526

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ice/

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r40

29.9

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356

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7B

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9430

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(25.

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4731

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834

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3031

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12,9

5535

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besi

tyI

(30.

0–34

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4228

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12.4

926

28.1

392

26.2

6639

22.1

8203

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sity

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5.0–

39.9

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316

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110

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194

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211

203.

714

374.

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ced/

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rate

d40

26.8

102

14.2

1014

30.9

327

22.0

4158

13.8

5724

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Wid

owed

2214

.892

12.8

684

20.9

203

13.6

4939

16.4

6012

16.6

Pres

entl

ym

arri

ed/

Livi

ngas

mar

ried

8557

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467

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22,9

6263

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t(c

m)

149

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6.1

720

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2�

5.8

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6�

6.4

1498

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3�

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30,0

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336

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0�

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ght

(kg)

149

80.6

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263

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13.5

3314

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15.9

30,1

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16.1

36,2

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Wai

st/h

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tio

(WH

R)

147

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�0.

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00.

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0188

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13.2

30,0

7088

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13.7

36,1

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13.7

Livi

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one

No

121

82.9

613

85.1

2391

73.1

1249

84.6

23,2

2677

.427

,952

77.6

Yes

2517

.110

714

.988

126

.922

715

.467

6622

.680

8522

.4U

.S.r

egio

nN

orth

east

2718

.130

4.2

537

16.2

161

10.7

7189

23.8

8019

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Sout

h39

26.2

425.

815

4546

.672

047

.862

1920

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3123

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4.2

921

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583.

877

5025

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2824

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6745

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085

.931

49.

556

837

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9529

.810

,804

29.8

Page 20: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

Smok

ing

Nev

ersm

oked

6846

.950

069

.515

9248

.994

363

.415

,424

51.6

18,7

5352

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stsm

oker

6242

.818

125

.212

7539

.144

329

.812

,262

41.1

14,3

8840

.1C

urre

ntsm

oker

1510

.338

5.3

391

12.0

101

6.8

2180

7.3

2761

7.7

Alc

ohol

inta

keN

ever

drin

ker

1711

.423

532

.651

315

.628

219

.126

498.

837

5410

.4Pa

stdr

inke

r41

27.5

148

20.6

1039

31.7

337

22.8

4748

15.8

6401

17.8

�1

drin

kpe

rm

o18

12.1

119

16.5

453

13.8

226

15.3

4165

13.9

5049

14.0

�1

drin

kpe

rw

k29

19.5

125

17.4

659

20.1

299

20.2

6417

21.4

7621

21.2

1–�

7dr

inks

per

wk

3020

.175

10.4

492

15.0

271

18.3

8435

28.1

9389

26.1

7�dr

inks

per

wk

149.

418

2.5

122

3.7

654.

435

5611

.938

1010

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ysic

alac

tivi

tyN

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tivi

ty28

20.3

126

17.8

792

25.5

343

24.7

4938

18.1

6324

19.2

Som

eac

tivi

ty69

50.0

319

45.0

1420

45.7

651

46.8

11,6

9142

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2–�

4ep

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rw

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218

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per

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�ac

tivi

ty23

16.7

132

18.6

451

14.5

223

16.0

5920

21.7

6824

20.7

Tot

alex

pend

itur

e/w

kfr

omph

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alac

tivi

ty(M

ETs)

0–1.

541

29.7

176

24.8

1050

33.8

463

33.3

6855

25.2

8709

26.4

�1.

5–8

4331

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225

.795

630

.740

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0229

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8929

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8–19

3525

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528

.966

721

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223

.272

8326

.786

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1919

13.8

146

20.6

437

14.1

203

14.6

5203

19.1

6087

18.4

Tot

alca

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min

take

(mg)

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117

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514

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336.

832

489.

140

0–�

800

3423

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431

.812

5439

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331

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800–

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0036

25.2

8512

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511

.419

213

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0214

.550

3014

.110

00–�

1200

1812

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12.2

238

7.5

162

11.3

3617

12.2

4170

11.7

1200

�35

24.5

188

26.7

539

16.9

424

29.5

11,1

8937

.712

,500

35.1

Any

supp

lem

ent

use

No

5436

.221

229

.416

6650

.269

646

.210

,090

33.5

12,8

7835

.5Y

es95

63.8

510

70.6

1651

49.8

811

53.8

20,0

6366

.523

,404

64.5

Mul

tivi

tam

inus

e(w

ith

orw

itho

utm

iner

als)

No

9966

.448

266

.825

7177

.511

2274

.518

,791

62.3

23,3

5464

.4Y

es50

33.6

240

33.2

745

22.5

385

25.5

11,3

6237

.712

,927

35.6

Vit

amin

Cas

sing

lesu

pple

men

tN

o11

577

.253

674

.228

1885

.012

5583

.323

,034

76.4

28,0

9477

.4Y

es34

22.8

186

25.8

499

15.0

252

16.7

7119

23.6

8188

22.6

Vit

amin

Eas

sing

lesu

pple

men

tN

o11

476

.550

169

.427

8383

.911

9579

.322

,297

73.9

27,2

2475

.0Y

es35

23.5

221

30.6

534

16.1

312

20.7

7856

26.1

9058

25.0

Cal

cium

assi

ngle

supp

lem

ent

(inc

ludi

ngan

taci

ds)

No

124

83.2

534

74.0

2911

87.8

1263

83.8

22,4

4274

.427

,626

76.1

Yes

2516

.818

826

.040

612

.224

416

.277

1125

.686

5623

.9Si

ngle

supp

lem

ent

(not

Vit

amin

C,E

,or

calc

ium

)N

o96

64.4

435

60.2

2501

75.4

1073

71.2

19,7

5665

.524

,147

66.6

Yes

5335

.628

739

.881

624

.643

428

.810

,397

34.5

12,1

3533

.4A

nysu

pple

men

t(e

xclu

ding

sing

lesu

pple

men

tca

lciu

m)

No

6040

.324

934

.518

0954

.575

450

.011

,551

38.3

14,6

0040

.2Y

es89

59.7

473

65.5

1508

45.5

753

50.0

18,6

0261

.721

,682

59.8

a Tot

alin

clud

esth

ose

ofun

know

net

hnic

ity.

*Dat

aw

ithh

eld

from

cells

whe

reN

�5

(�10

whe

reda

taar

ese

nsit

ive)

.

Page 21: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

AP

PE

ND

IXT

AB

LE

5.B

asel

ine

dem

ogra

phic

and

gene

ral

heal

thch

arac

teri

stic

sof

WH

IO

bser

vati

onal

Stud

ypa

rtic

ipan

tsby

race

/eth

nici

ty

Rac

e/Et

hnic

ity

Am

eric

anIn

dian

Asi

an/P

acifi

cB

lack

His

pani

cW

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Tot

ala

(N�

422)

Isla

nder

(N�

2671

)(N

�76

39)

(N�

3623

)(N

�78

,013

)(N

�93

,676

)

Cha

ract

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N%

Mea

n�

SDN

%M

ean

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N%

Mea

n�

SDN

%M

ean

�SD

N%

Mea

n�

SDN

%M

ean

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Age

atsc

reen

ing

(y)

422

61.7

�7.

926

7163

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7.6

7639

62.1

�7.

336

2360

.6�

7.1

78,0

1363

.9�

7.3

93,6

7663

.6�

7.4

50–5

917

842

.286

132

.229

7839

.017

6148

.623

,565

30.2

29,7

0531

.760

–69

161

38.2

1102

41.3

3256

42.6

1399

38.6

34,6

7744

.541

,197

44.0

70–7

983

19.7

708

26.5

1405

18.4

463

12.8

19,7

7125

.322

,774

24.3

Educ

atio

n0–

8y

4611

.065

2.5

277

3.7

630

17.7

518

0.7

1560

1.7

Som

ehi

ghsc

hool

4611

.095

3.6

726

9.6

318

8.9

2032

2.6

3288

3.5

Hig

hsc

hool

dipl

oma/

GED

6916

.541

615

.710

4713

.956

415

.912

,784

16.5

15,1

2116

.3Sc

hool

afte

rhi

ghsc

hool

166

39.7

891

33.6

2789

37.0

1249

35.1

28,3

3236

.633

,933

36.5

Col

lege

degr

eeor

high

er91

21.8

1185

44.7

2692

35.7

796

22.4

33,7

8143

.639

,002

42.0

Fam

ilyin

com

e�

$10,

000

6717

.684

3.4

967

13.9

544

17.1

2175

3.0

3916

4.5

$10,

000–

$19,

999

7820

.524

19.

712

5218

.063

920

.177

0410

.610

,100

11.6

$20,

000–

$34,

999

9625

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Page 23: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

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Page 24: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

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Page 25: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

AP

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Page 26: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

His

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Page 27: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

AP

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171.

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6

Page 28: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

Num

ber

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Page 29: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

AP

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Page 30: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

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Page 31: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

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315

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3954

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55.4

286

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1317

.821

13.2

261

17.2

125

21.6

941

12.0

1375

13.3

Page 32: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

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Page 33: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

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Page 34: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

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Page 35: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

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Page 36: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

His

tory

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Yes

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ory

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742

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Page 37: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

AP

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Page 38: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

His

tory

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His

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197

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99.7

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98.6

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1.3

603

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198

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5168

99.5

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8399

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(con

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Page 39: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

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tory

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00

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tory

ofD

VT

No

145

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719

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**

**

892.

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1.7

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2.8

973

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His

tory

ofPE

No

148

99.3

717

99.4

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No

146

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720

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**

**

702.

120

1.3

254

0.8

350

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His

tory

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roke

No

147

98.7

716

99.2

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60.

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2.1

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age

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f

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110

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509

90.6

2243

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hip

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ture

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999

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**

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Num

ber

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last

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4.3

Page 44: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

His

tory

ofca

ncer

g

No

144

96.6

694

96.8

3156

96.5

1452

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5995

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53.

423

3.2

116

3.5

392.

612

414.

214

434.

0H

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ryof

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ncer

No

148

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015

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0*

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tory

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tory

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399

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d Bas

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and

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Page 45: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

AP

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50.0

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2091

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8521

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18,8

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330

9.2

7940

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389

93.1

2347

88.0

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Page 46: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

Age

attu

bal

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8421

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15.8

185

11.2

358

12.2

282

16.1

3644

8.5

4590

9.2

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155

84.2

1473

88.8

2588

87.8

1473

83.9

39,1

1291

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90.8

Tot

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271

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1757

65.8

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9957

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37,8

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392

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Page 47: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

AP

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Page 48: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

His

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2664

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379.

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430

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358

86.5

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92.1

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310

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401

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97.3

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94.6

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184.

373

2.7

449

5.9

119

3.3

4301

5.5

5021

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His

tory

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415

98.6

2642

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7506

98.5

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61.

426

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917

211.

8

(con

tinue

d)

Page 49: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

AP

PE

ND

IXT

AB

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409

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99.9

7525

99.7

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1099

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Page 50: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

S67Hays et al.THE WHI RECRUITMENT METHODS AND RESULTS

AEP Vol. 13, No. S9October 2003: S18–S77

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ND

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Page 51: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

S68 Hays et al.THE WHI RECRUITMENT METHODS AND RESULTS

AEP Vol. 13, No. S9October 2003: S18–S77

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Page 52: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

S69Hays et al.THE WHI RECRUITMENT METHODS AND RESULTS

AEP Vol. 13, No. S9October 2003: S18–S77

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Page 53: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

S70 Hays et al.THE WHI RECRUITMENT METHODS AND RESULTS

AEP Vol. 13, No. S9October 2003: S18–S77

AP

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ND

IXT

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Page 54: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

S71Hays et al.THE WHI RECRUITMENT METHODS AND RESULTS

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Page 55: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

S72 Hays et al.THE WHI RECRUITMENT METHODS AND RESULTS

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Page 56: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

S73Hays et al.THE WHI RECRUITMENT METHODS AND RESULTS

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Page 57: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

S74 Hays et al.THE WHI RECRUITMENT METHODS AND RESULTS

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Page 58: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

S75Hays et al.THE WHI RECRUITMENT METHODS AND RESULTS

AEP Vol. 13, No. S9October 2003: S18–S77

AP

PE

ND

IXT

AB

LE

19.

Bas

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Page 59: The Women’s Health Initiative Recruitment … Monograph/baseline...Hays et al. S19 THE WHI RECRUITMENT METHODS AND RESULTS AEP Vol. 13, No. S9 October 2003: S18–S77 were still

S76 Hays et al.THE WHI RECRUITMENT METHODS AND RESULTS

AEP Vol. 13, No. S9October 2003: S18–S77

AP

PE

ND

IXT

AB

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