Overview of recruitment for the osteoporotic fractures in men study (MrOS)

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Abstract

Large, long term research studies present recruitment challenges that can be met with collaborative approaches to identify and enroll participants. The Osteoporotic Fractures in Men Study (MrOS), a multi-center observational study designed to determine risk factors for osteoporosis, fractures and prostate cancer in older men, recruited 5995 participants over a 25-month period. Enrolling a cohort that represented the race and age distribution of each community, and developing interest in an older male cohort about a condition commonly thought of as a “women's disease,” were major recruitment challenges. During the start-up phase, recruitment challenges and strategies were analyzed and collective approaches were developed to address ways to motivate the target population. Key methods included mailings using community and provider contact lists; regional and senior newspaper advertisements; and presentations targeted to seniors. Sites used a centrally developed recruitment brochure. Response to mass mailings at some sites surpassed 10–15% and appointment show rates averaged above 85%. The final number enrolled in MrOS was 5% more than the original recruitment goal of 5700. Minority recruitment was enhanced through the use of the Health Care Financing Administration and other databases that allowed for targeted recruitment. Overall, minority enrollment was ∼10.56% of the cohort (244 African American, 191 Asian). Men age > 80 were enthusiastic and represent about 18% of enrollees. Through a coordinated approach of developing and refining recruitment strategies and materials, sites were able to adapt their original strategies and complete recruitment ahead of schedule.

Section snippets

MrOS study hypothesis and design

The Osteoporotic Fractures in Men Study (MrOS) is a 7-year prospective, observational study designed to determine risk factors for osteoporosis and fractures, to understand age-related medical conditions and risk factors including, but not limited to fall risk, and to understand the relationship with prostate disease in men 65 years of age and older. Vertebral fracture, the most common osteoporotic fracture in men, is the primary outcome in this study with all non-vertebral fractures, as

Recruitment design and study population

A total of 5700 men aged 65 years or older were to be recruited from the populations at the six clinical sites: Each site would enroll 950 men. Based on 1990 census data from the areas to be included (www.census.gov), we anticipated that 80% of the total study population would be white non-Hispanic, 3% would be Asian, 3% would be Hispanic, and 14% would be black non-Hispanic.

The MrOS cohort was designed to be representative of community dwelling, ambulatory men aged 65 years or older.

Study-wide recruitment objectives, challenges, and strategies

Recruitment challenges were to identify appropriate sources of age-eligible men; to gain their interest and commitment to participate in a long-term research study; to identify and develop successful outreach that would allow sites to enroll a representative minority population; and to overcome a common perception that osteoporosis and fracture risk were conditions thought to be of concern only to women.

Each center designated a site coordinator to manage, assess, and report on recruitment

Overview of recruitment at clinical sites

During the proposal process, each site developed recruitment strategies and methods taking into account the characteristics and logistics of recruiting within their community. Each site followed standard recruitment practices by developing multiple, step-wise or simultaneous methods that would allow for a full and consistent pipeline of potential participants. Each site also had dedicated trained staff responsible for coordinating recruitment and for monitoring performance and progress.

Recruitment results

At the end of the recruitment period (March 2000 through April 2002) 5995 participants had completed all baseline measurements required for study eligibility (spine X-ray, hip DEXA, height, weight, and self-administered questionnaire). As shown in Table 3, mass mailings were the most productive recruitment source at most sites with the HCFA mailing database accounting for around half of the respondents at Birmingham and San Diego. Minneapolis and Palo Alto used word of mouth and referrals at a

Summary and discussion

Regardless of the target population, recruitment for a long-term, multi-center, observational study is complex and presents many challenges for the study management and clinical sites. The MrOS investigators and site personnel brought a wide-range of experience in conducting studies and in collaborating on recruitment methods and strategies for recruitment. Sites had well defined recruitment plans at the time of the grant submission and the high level of collaboration among investigators,

Acknowledgements

The Osteoporotic Fractures in Men (MrOS) Study is supported by the National Institutes of Health funding. The following institutes provide support: the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Aging (NIA), and the National Cancer Institute (NCI), under the following grant numbers: U01-AR45647, AR45580, AR45614, AR45632, AR45654, AR45583, AG18197, and M01 RR000334. For information regarding MrOS contact Eric S. Orwoll, MD, OHSU.

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