Preference assessment of recruitment into a randomized trial for adolescent idiopathic scoliosis

Journal of Bone and Joint Surgery

Volumn 90, Issue 12, 2008, Pages 2594-2605

  Dolan, Lori A ^a   Sabesan, Vani ^b   Weinstein, Stuart L ^a   Spratt, Kevin F ^c  

^a UNIVERSITY OF IOWA HEALTH CARE   (United States)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

^c DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADOLESCENT; ARTICLE; BRACE; CHILD; FEMALE; HUMAN; IDIOPATHIC SCOLIOSIS; MAJOR CLINICAL STUDY; MALE; MEDICAL DECISION MAKING; PATIENT SATISFACTION; PATIENT SELECTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; TREATMENT OUTCOME; TREATMENT REFUSAL;

EID: 57349170299     PISSN: 00219355     EISSN: None     Source Type: Journal    
DOI: 10.2106/JBJS.G.01460     Document Type: Article

References (74)

1. Halpern SD. Prospective preference assessment: a method to enhance the ethics and efficiency of randomized controlled trials. Cont Clin Trials. 2002;23:274-88.
2. Creel AH, Losina E, Mandl LA, Marx RJ, Mahomed NN, Martin SD, Martin TL, Millett PJ, Fossel AH, Katz JN. An assessment of willingness to participate in a randomized trial of arthroscopic knee surgery in patients with osteoarthritis. Cont ClinTrials. 2005;26:169-78.
3. Stone B, Beekman C, Hall V, Guess V, Brooks HL. The effect of an exercise program on change in curve in adolescents with minimal idiopathic scoliosis. A preliminary study. Phys Ther. 1979;59:759-63.
4. Durham JW, Moskowitz A, Whitney J. Surface electrical stimulation versus brace in treatment of idiopathic scoliosis. Spine. 1990;15:888-92.
5. Nachemson AL, Peterson LE. Effectiveness of treatment with a brace in girls who have adolescent idiopathic scoliosis. A prospective, controlled study based on data from the Brace Study of the Scoliosis Research Society. J Bone Joint Surg Am. 1995;77:815-22.
6. Allington NJ, Bowen JR. Adolescent idiopathic scoliosis: treatment with the Wilmington brace. A comparison of full-time and part-time use. J Bone Joint Surg Am. 1996;78:1056-62.
7. Bassett GS, Bunnell WP. Influence of the Wilmington brace on spinal decompensation in adolescent idiopathic scoliosis. Clin Orthop Relat Res. 1987;223:164-9.
8. Bunnell WP. Nonoperative treatment of spinal deformity: the case for observation. Instr Course Lect. 1985;34:106-9.
9. Carr WA, Moe JH, Winter RB, Lonstein JE. Treatment of idiopathic scoliosis in the Milwaukee brace. J Bone Joint Surg Am. 1980;62:599-612.
10. Edmonsson AS, Morris JT. Follow-up study of Milwaukee brace treatment in patients with idiopathic scoliosis. Clin Orthop Relat Res. 1977;126:58-61.
11. Emans JB, Kaelin A, Bancel P, Hall JE, Miller ME. The Boston bracing system for idiopathic scoliosis. Follow-up results in 295 patients. Spine. 1986;11:792-801.
12. Goldberg CJ, Dowling FE, Hall JE, Emans JB. A statistical comparison between natural history of idiopathic scoliosis and brace treatment in skeletally immature adolescent girls. Spine. 1993;18:902-8.
13. Hanks GA, Zimmer B, Nogi J. TLSO treatment of idiopathic scoliosis. An analysis of the Wilmington jacket. Spine. 1988;13:626-9.
14. Lonstein JE, Winter RB. The Milwaukee brace for the treatment of adolescent idiopathic scoliosis. A review of one thousand and twenty patients. J Bone Joint Surg Am. 1994;76:1207-21.
15. Mellencamp DD, Blount WP, Anderson AJ. Milwaukee brace treatment of idiopathic scoliosis: late results. Clin Orthop Relat Res. 1977;126:47-57.
16. Moe JH, Kettleson DN. Idiopathic scoliosis. Analysis of curve patterns and the preliminary results of Milwaukee-brace treatment in one hundred sixty-nine patients. J Bone Joint Surg Am. 1970;52:1509-33.
17. Montgomery F, Willner S. Prognosis of brace-treated scoliosis. Comparison of the Boston and Milwaukee methods in 244 girls. Acta Orthop Scand. 1989;60:383-5.
18. Noonan KJ, Weinstein SL, Jacobson WC, Dolan LA. Use of the Milwaukee brace for progressive idiopathic scoliosis. J Bone Joint Surg Am. 1996;78:557-67.
19. Fernandez-Feliberti R, Flynn J, Ramirez N, Trautmann M, Alegria M. Effectiveness of TLSO bracing in the conservative treatment of idiopathic scoliosis. J Pediatr Orthop. 1995;15:176-81.
20. Goldberg CJ, Moore DP, Fogarty EE, Dowling FE. Adolescent idiopathic scoliosis: the effect of brace treatment on the incidence of surgery. Spine. 2001;26:42-7.
21. Miller JA, Nachemson AL, Schultz AB. Effectiveness of braces in mild idiopathic scoliosis. Spine. 1984;9:632-5.
22. Rowe DE, Bernstein SM, Riddick MF, Adler F, Emans JB, Gardner-Bonneau D. A meta-analysis of the efficacy of non-operative treatments for idiopathic scoliosis. J Bone Joint Surg Am. 1997;79:664-74.
23. Karol LA. Effectiveness of bracing in male patients with idiopathic scoliosis. Spine. 2001;26:2001-5.
24. Katz DE, Durrani AA. Factors that influence outcome in bracing large curves in patients with adolescent idiopathic scoliosis. Spine. 2001;26:2354-61.
25. Green NE. Part-time bracing of adolescent idiopathic scoliosis. J Bone Joint Surg Am. 1986;68:738-42.
26. Price CT, Scott DS, Reed FR Jr, Sproul JT, Riddick MF. Nighttime bracing for adolescent idiopathic scoliosis with the Charleston Bending Brace: long-term follow-up. J Pediatr Orthop. 1997;17:703-7.
27. Upadhyay SS, Nelson IW, Ho EK, Hsu LC, Leong JC. New prognostic factors to predict the final outcome of brace treatment in adolescent idiopathic scoliosis. Spine. 1995;20:537-45.
28. Andriacchi TP, Schultz AB, Belytschko TB, DeWald R. Milwaukee brace correction of idiopathic scoliosis. A biomechanical analysis and a retrospective study. J Bone Joint Surg Am. 1976;58:806-15.
29. Olafsson Y, Saraste H, Soderlund V, Hoffsten M. Boston brace in the treatment of idiopathic scoliosis. J Pediatr Orthop. 1995;15:524-7.
30. Danielsson AJ, Hasserius R, Ohlin A, Nachemson AL. A prospective study of brace treatment versus observation alone in adolescent idiopathic scoliosis: a follow-up mean of 16 years after maturity. Spine. 2007;32:2198-207.
31. Dolan LA, Donnelly MJ, Spratt KF, Weinstein SL. Professional opinion concerning the effectiveness of bracing relative to observation in adolescent idiopathic scoliosis. J Pediatr Orthop. 2007;27:270-6.
32. Coillard C, Vachon V, Circo AB, Beausejour M, Rivard CH. Effectiveness of the SpineCor brace based on the new standardized criteria proposed by the scoliosis research society for adolescent idiopathic scoliosis. J Pediatr Orthop. 2007;27:375-9.
33. Janicki JA, Poe-Kochert C, Armstrong DG, Thompson GH. A comparison of the thoracolumbosacral orthoses and providence orthosis in the treatment of adolescent idiopathic scoliosis: results using the new SRS inclusion and assessment criteria for bracing studies. J Pediatr Orthop. 2007;27:369-74.
34. Lenssinck ML, Frijlink AC, Berger MY, Bierman-Zeinstra SM, Verkerk K, Verhagen AP. Effect of bracing and other conservative interventions in the treatment of idiopathic scoliosis in adolescents: a systematic review of clinical trials. Phys Ther. 2005;85:1329-39.
35. Negrini S, Marchini G. Efficacy of the symmetric, patient-oriented, rigid, three-dimensional, active (SPoRT) concept of bracing for scoliosis: a prospective study of the Sforzesco versus Lyon brace. Eura Medicophys. 2007;43:171-81;183-4.
36. Weiss HR, Weiss GM. Brace treatment during pubertal growth spurt in girls with idiopathic scoliosis (IS): a prospective trial comparing two different concepts. Pediatr Rehabil. 2005;8:199-206.
37. Weiss HR, Werkmann M, Stephan C. Correction effects of the ScoliOlogiC "Chěneau light" brace in patients with scoliosis. Scoliosis. 2007;2:2.
38. Yrjönen T, Ylikoski M, Schlenzka D, Poussa M. Results of brace treatment of adolescent idiopathic scoliosis in boys compared with girls: a retrospective study of 102 patients treated with the Boston brace. Eur Spine J. 2007;16:393-7.
39. Llewellyn-Thomas HA, McGreal MJ, Thiel EC, Fine S, Erlichman C. Patients' willingness to enter clinical trials: measuring the association with perceived benefit and preference for decision participation. Soc Sci Med. 1991;32:35-42.
40. Feldman-Stewart D, Brundage MD, Van Manen L. A decision aid for men with early stage prostate cancer: theoretical basis and a test by surrogate patients. Health Expect. 2001;4:221-34.
41. Llewellyn-Thomas HA, Thiel EC, Clark RM. Patients versus surrogates: whose opinion counts on ethics review panels? Clin Res. 1989;37:501-5.
42. McNeil BJ, Pauker SG, Sox HC Jr, Tversky A. On the elicitation of preferences for alternative therapies. N Engl J Med. 1982;306:1259-62.
43. Naylor CD, Llewellyn-Thomas HA. Can there be a more patient-centred approach to determining clinically important effect sizes for randomized treatment trials? J Clin Epidemiol. 1994;47:787-95.
44. Halpern SD, Karlawish JH, Casarett D, Berlin JA, Townsend RR, Asch DA. Hypertensive patients' willingness to participate in placebo-controlled trials: implications for recruitment efficiency. Am Heart J. 2003;146:985-92.
45. Wragg JA, Robinson EJ, Lilford RJ. Information presentation and decisions to enter clinical trials: a hypothetical trial of hormone replacement therapy. Soc Sci Med. 2000;51:453-62.
46. Donovan J, Hamdy F, Neal D, Peters T, Oliver S, Brindle L, Jewell D, Powell P, Gillatt D, Dedman D, Mills N, Smith M, Noble S, Lane A; ProtecT Study Group. Prostate Testing for Cancer and Treatment (ProtecT) feasibility study. Health Technol Assess. 2003;7:1-88.
47. Llewellyn-Thomas HA, Paterson JM, Carter JA, Basinsk A, Myers MG, Hardacre GD, Dunn EV, D'Agostino RB, Wolf PA, Naylor CD. Primary prevention drug therapy: can it meet patients' requirements for reduced risk? Med Decis Making. 2002;22:326-39.
48. Llewellyn-Thomas HA. Investigating patients' preferences for different treatment options. Can J Nurs Res. 1997;29:45-64.
49. Llewellyn-Thomas HA, Williams JI, Levy L, Naylor CD. Using a trade-off technique to assess patients' treatment preferences for benign prostatic hyperplasia. Med Decis Making. 1996;16:262-82.
50. Brundage MD, Davidson JR, MacKillop WJ, Feldman-Stewart D, Groome P. Using a treatment-tradeoff method to elicit preferences for the treatment of locally advanced non-small-cell lung cancer. Med Decis Making. 1998;18:256-67.
51. Sung L, Feldman BM, Schwamborn G, Paczesny D, Cochrane A, Greenberg ML, Maloney AM, Hendershot EI, Naqvi A, Barrera M, Llewellyn-Thomas HA. Inpatient versus outpatient management of low-risk pediatric febrile neutropenia: measuring parents' and healthcare professionals' preferences. J Clin Oncol. 2004;22:3922-9.
52. Donnelly MJ, Dolan LA, Grande L, Weinstein SL. Patient and parent perspectives on treatment for adolescent idiopathic scoliosis. Iowa Orthop J. 2004;24:76-83.
53. Stiggelbout AM, Kiebert GM. A role for the sick role. Patient preferences regarding information and participation in clinical decision-making. CMAJ. 1997;157:383-9.
54. Degner LF, Russell CA. Preferences for treatment control among adults with cancer. Res Nurs Health. 1988;11:367-74.
55. Deber RB, Kraetschmenr N, Irvine J. What role do patients wish to play in treatment decision-making? Arch Int Med. 1996;156:1414-20.
56. Auerbach SM. Should patients have control over their own health care? Empirical evidence and research issues. Ann Behav Med. 2000;22:246-59.
57. Morrow GR. Hickok JT, Burish TG. Behavioral aspects of clinical trials. An integrated framework from behavior theory. Cancer. 1994;74(9 Suppl):2676-82.
58. Cassileth BR, Zupkis RV, Sutton-Smith K, March V. Information and participation preferences among cancer patients. Ann Intern Med. 1980;92:832-6.
59. Advani AS, Atkeson B, Brown CL, Peterson BL, Fish L, Johnson JL, Gockerman JP, Gautier M. Barriers to the participation of African-American patients with cancer in clinical trials: a pilot study. Cancer. 2003;97:1499-506.
60. Cox K, McGarry J. Why patients don't take part in cancer clinical trials: an overview of the literature. Eur J Cancer Care (Engl). 2003;12:114-22.
61. Gotay CC. Accrual to cancer clinical trials: directions from the research literature. Soc Sci Med. 1991;33:569-77.
62. Ross SA, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52:1143-56.
63. Ellis PM. Attitudes towards and participation in randomised clinical trials in oncology: a review of the literature. Ann Oncol. 2000;11:939-45.
64. Schain WS. Barriers to clinical trials. Part II: Knowledge and attitudes of potential participants. Cancer. 1994;74(9 Suppl):2666-71.
65. Verheggen FW, Nieman F, Jonkers R. Determinants of patient participation in clinical studies requiring informed consent: why patients enter a clinical trial. Patient Educ and Couns. 1998;35:111-25.
66. Wiley FM, Ruccione K, Moore IM, McGuire-Cullen P, Fergusson J, Waskerwitz MJ, Perin G, Ge J, Sather HN. Parents' perceptions of randomization in pediatric clinical trials. Cancer Pract. 1999;7:248-56.
67. Zupancic JA, Gillie P, Streiner DL, Watts JL, Schmidt B. Determinants of parental authorization for involvement of newborn infants in clinical trials. Pediatrics. 1997;99:E6.
68. Dolan LA, Weinstein SL. Surgical rates after observation and bracing for adolescent idiopathic scoliosis: an evidence-based review. Spine. 2007;32(19 Suppl):S91-S100.
69. Autret E, Dutertre JP, Barbier P, Jonville AP, Pierre F, Berger C. Parental opinions about biomedical research in children in Tours, France. Dev Pharacol Ther. 1993;20:64-71.
70. Grant CH 3rd, Cissna KN, Rosenfeld LB. Patients' perceptions of physicians communication and outcomes of the accrual to trial process. Health Commun. 2000;12:23-39.
71. Mills N, Donovan JL, Smith M, Jacoby A, Neal DE, Hamdy FC. Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT study. Control Clin Trials. 2003;24:272-82.
72. Brundage M, Feldman-Stewart D, Cosby R, Gregg R, Dixon P, Youssef Y, MacKillop W. Cancer patients' attitudes toward treatment options for advanced non-cell lung cancer: implications for patient education and decision support. Patient Educ Couns. 2001;45:149-57.
73. Rosenbaum JR, Wells CK, Viscoli CM, Brass LM, Kernan WN, Horwitz RI. Altruism as a reason for participation in clinical trials was independently associated with adherence. J Clin Epidemiol. 2005;58:1109-14.
74. Morton A, Riddle R, Buchanan R, Katz D, Birch J. Accuracy in the prediction and estimation of adherence to bracewear before and during treatment of adolescent idiopathic scoliosis. J Pediatr Orthop. 2008;28:336-41.