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