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Preference Assessment of Recruitment into a Randomized Trial for Adolescent Idiopathic Scoliosis
Lori A. Dolan, PhD1; Vani Sabesan, MD2; Stuart L. Weinstein, MD1; Kevin F. Spratt, PhD3
1 Department of Orthopaedics and Rehabilitation, University of Iowa Health Care, 200 Hawkins Drive, Iowa City, IA 52242. E-mail address for L.A. Dolan: lori-dolan@uiowa.edu
2 Division of Orthopaedic Surgery, Duke University Medical Center, 200 Trent Drive, Box 3956, Durham, NC 27710
3 Department of Orthopaedics, Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756
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Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases (1 R21 AR049587-01) and The Children's Miracle Network. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.
Investigation performed at the University of Iowa Hospitals and Clinics, Iowa City, Iowa; the University of Virginia, Charlottesville, Virginia; Columbia University, New York, NY; Children's Hospital of San Diego, San Diego, California; and Shriners Hospital for Crippled Children, Erie, Pennsylvania

The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2008 Dec 01;90(12):2594-2605. doi: 10.2106/JBJS.G.01460
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Background: Randomized controlled trials are powerful tools to evaluate the outcomes of clinical treatments. However, these trials tend to be expensive and time-consuming, and their conclusions can be threatened by several limitations. This study estimated the strength of three common limitations (underenrollment, selective enrollment, and nonadherence to protocol) in a proposed study of adolescent idiopathic scoliosis.

Methods: Patients with scoliosis and their parents were asked to complete a web-based survey about their preferences concerning a hypothetical randomized trial. Adolescents without scoliosis and their parents also participated. Surveys included questions about treatment preference, likelihood of participation, required risk reduction, and propensity to drop out or choose a different treatment while enrolled in the study.

Results: Ninety adolescents and eighty-three parents participated. Observation was preferred to bracing by the majority of subjects. Overall, 33% of the parents and adolescents would both agree to participate in the hypothetical trial. Of the subjects who would not agree to participate, the majority would rather share the decision-making responsibility with the physician than have the treatment chosen in a random fashion. Many of the subjects would consider changing treatments during the course of the trial if they were not satisfied with the outcomes; the majority of parents who preferred bracing would consider crossing over to the bracing arm if their children were randomized to observation.

Conclusions: Recruitment into a randomized trial of bracing compared with observation for the treatment of adolescent idiopathic scoliosis may well be problematic, considering the relatively small percentage of families who said they would consider randomization. Additionally, the threat of nonadherence to protocol may be strong and must be addressed in the protocol of the trial. Most families wanted to make the treatment decision with the physician in lieu of randomization; therefore, the role of the physician in patient recruitment and retention should not be underestimated.

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    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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