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

Creel AH, Losina E, Mandl LA, Marx RJ, Mahomed NN, Martin SD, Martin TL, Millett PJ, Fossel AH, Katz JN

Section of Clinical Sciences, Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, USA.

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.

Published 19 April 2005 in Contemp Clin Trials, 26(2): 169-78.
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