Determinants of subject visit participation in a prospective cohort study of HTLV infection

Abstract

BackgroundUnderstanding participation in a prospective study is crucial to maintaining and improving retention rates. In 1990–92, following attempted blood donation at five blood centers, we enrolled 155 HTLV-I, 387 HTLV-II and 799 HTLV seronegative persons in a long-term prospective cohort.MethodsHealth questionnaires and physical exams were administered at enrollment and 2-year intervals through 2004. To examine factors influencing attendance at study visits of the cohort participants we calculated odds ratios (ORs) with generalized estimated equations (GEE) to analyze fixed and time-varying predictors of study visit participation.ResultsThere were significant independent associations between better visit attendance and female gender (OR = 1.31), graduate education (OR = 1.86) and income > $75,000 (OR = 2.68). Participants at two centers (OR = 0.47, 0.67) and of Black race/ethnicity (OR = 0.61) were less likely to continue. Higher subject reimbursement for interview was associated with better visit attendance (OR = 1.84 for $25 vs. $10). None of the health related variables (HTLV status, perceived health status and referral to specialty diagnostic exam for potential adverse health outcomes) significantly affected participation after controlling for demographic variables.ConclusionIncreasing and maintaining participation by minority and lower socioeconomic status participants is an ongoing challenge in the study of chronic disease outcomes. Future studies should include methods to evaluate attrition and retention, in addition to primary study outcomes, including qualitative analysis of reasons for participation or withdrawal.

A trial of 3 interventions to promote colorectal cancer screening in African Americans

“…Continued participation represents a low priority for participants, especially since the benefits may not be apparent. We have observed this in previous projects, 21 as have others; in particular, low income, less education, and African-American race have been associated with attrition from research projects 22. Brown and colleagues23 identified lack of awareness, lack of transportation, interference with work/family responsibilities, financial costs, negative side effects, and burdensome procedures as barriers, and it is likely that all of these played a role in our project.…”

Retention of clinical trial participants in a study of Nongonococcal Urethritis (NGU), a sexually transmitted infection in men

“…Participants in the microbicide trials may have been more highly motivated by the prospect of preventing a life-threatening disease. There are mixed reports on the role of gender on retention to clinical trials which enrolled both men and women [7, 19, 30, 32]. Retention rates did not vary by gender in studies of HIV-infected individuals and persons at high risk for HIV [7, 30, 32].…”

“…Retention rates did not vary by gender in studies of HIV-infected individuals and persons at high risk for HIV [7, 30, 32]. In a trial of HTLV patients, men were more likely to be lost to follow-up than women [19]. …”

“…In a HIV prevention study of African-American men between 16 and 20 years of age, 77% and 65% returned for the 3-month and 6-month visits, respectively [27]. Attendance at one or more follow-up visits was reported in 76% of minority patients who were positive for the human T-cell lymphotropic virus (HTLV) [19]. …”

Assessing the Remedy: The Case for Contracts in Clinical Trials

“…In this vein, there is a growing body of empirical literature on what factors might predict reliability (Martin et al 2000) so they can be screened out (Sprague 2003). Age, ethnic identity, previous nonadherence, low understanding or educational level, complex and rigid treatment regimens, delays before actual participation, and lack of a run-in phase have each been associated with early drop-out (El-Khorazaty et al 2007;Agosti et al 1996;Goldman et al 1982;Langford et al 2010;Groeneveld et al 2009;Larson et al 2009;Ulmer et al 2008;Fabricatore et al 2009;DeVita et al 2009;Haring et al 2009;Siddiqi et al 2008;Williams et al 2008). These studies mostly involved health promotion interventions and long-term observations, while three were pharmaceutical (Goldman et al 1982;Fabricatore et al 2009;DeVita et al 2009).…”