An assessment of willingness to participate in a randomized trial of arthroscopic knee surgery in patients with osteoarthritis

Boston University, Boston, Massachusetts, United States
Contemporary Clinical Trials (Impact Factor: 1.94). 05/2005; 26(2):169-78. DOI: 10.1016/j.cct.2004.12.010
Source: PubMed


Identifying barriers to recruitment into a randomized clinical trial can help researchers adjust recruitment strategies to maximize enrollment. To determine barriers to enrollment of patients in trials of knee osteoarthritis treatments, we recruited from three centers patients over age 45 who had both knee osteoarthritis and a meniscal tear. We described a hypothetical randomized trial of arthroscopic partial meniscectomy versus non-operative management and assessed patients' willingness to participate in such a trial. We elicited preferences for treatment along with information on age, sex, education level, race, work status, and pain. We examined the association between these factors and willingness to participate in the trial. Orthopedic surgeons identified 106 eligible osteoarthritis patients, of whom 12 could not be reached, 6 refused and 88 (83%) completed interviews. 63% were female, 55% were college graduates, 23% were non-white and mean age was 60+/-8. The mean WOMAC pain score was 56+/-23. 22% of patients stated that they were definitely willing to participate in the hypothetical trial, and 24% stated they were probably willing. Subjects lacking strong preferences for treatment stated a greater willingness to participate than those with strong preferences (36-14% definitely willing, chi(2) for trend, p=0.005). WOMAC pain score, age, education, work status and race were not associated with willingness to participate. Males were more likely than females to state a willingness to participate (39-11% definitely willing, p=0.005). Since OA affects females disproportionately, a better understanding of barriers to females' participation in trials may enhance future research on treatment of osteoarthritis. Effectively addressing a priori treatment preferences through patient education about the advantages and drawbacks of treatments may increase willingness to participate in trials.

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Available from: Alisha Heather Creel
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    • "The influence of patients' preferences and perceptions of equipoise on compliance and willingness to participate is not well explored, and often based on hypothetical trials [8-10]. Even among participants who agree and understand both clinical equipoise and the process of randomisation, about 10–15% still have a preference for a particular treatment and hope to be randomised to that particular treatment arm [8,11]. "
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    • "While some studies report no association between recruitment rates and education [13] [14], other literature suggests that individuals with a lower level of education are less likely to participate in clinical trials [6,15–21]. As chronic diseases often disproportionately affect the elderly, the poor, and those with lower educational attainment, recruiting these populations for clinical trials in chronic diseases is important but may be particularly difficult [22]. "
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