Effectiveness of the head CT choice decision aid in parents of children with minor head trauma: Study protocol for a multicenter randomized trial

Trials

Volumn 15, Issue 1, 2014, Pages

  Hess, Erik P ^a   Wyatt, Kirk D ^b   Kharbanda, Anupam B ^c   Louie, Jeffrey P ^d   Dayan, Peter S ^e   Tzimenatos, Leah ^f   Wootton Gorges, Sandra L ^f   Homme, James L ^a   RN, Laurie P ^a   LeBlanc, Annie ^a   Westphal, Jessica J ^g   Shepel, Kathy ^a   Shah, Nilay D ^a   Branda, Megan ^a   Herrin, Jeph ^h,i   Montori, Victor M ^a   Kuppermann, Nathan ^f  

^a MAYO CLINIC   (United States)

^b Mayo Clinic   (United States)

^c CHILDREN S HOSPITALS AND CLINICS OF MINNESOTA   (United States)

^d UNIVERSITY OF MINNESOTA   (United States)

^e Mayo Medical School Mayo Clinic College of Medicine ^*  (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g Parent Representative   (United States)

^h YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ Health Research and Educational Trust   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BLUNT TRAUMA; CLINICAL EFFECTIVENESS; COMPUTER ASSISTED TOMOGRAPHY; CONFLICT; CONTROLLED STUDY; DECISION SUPPORT SYSTEM; ELECTRONIC MEDICAL RECORD; EMERGENCY WARD; FOLLOW UP; HEAD INJURY; HEALTH CARE UTILIZATION; HEALTH SURVEY; HOSPITAL BILLING; HUMAN; KNOWLEDGE; MEDICAL DECISION MAKING; MEDICAL RECORD REVIEW; MULTICENTER STUDY; PARENT; PATIENT CARE; PATIENT SAFETY; PATIENT SATISFACTION; RADIATION EXPOSURE; RADIATION HAZARD; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; SKULL; SOCIAL MEDIA; TELEPHONE INTERVIEW; TRAUMATIC BRAIN INJURY; TRUST; VIDEORECORDING; CHILD; CLINICAL TRIAL; DECISION MAKING; INJURY SCALE; METHODOLOGY; PROCEDURES; RADIOGRAPHY; RISK ASSESSMENT; WATCHFUL WAITING;

CHILD; CONFLICT (PSYCHOLOGY); CRANIOCEREBRAL TRAUMA; DECISION MAKING; DECISION SUPPORT TECHNIQUES; HUMANS; PARENTS; RESEARCH DESIGN; RISK ASSESSMENT; TOMOGRAPHY, X-RAY COMPUTED; TRAUMA SEVERITY INDICES; WATCHFUL WAITING;

EID: 84902915480     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-15-253     Document Type: Article

References (33)

1. Faul M, Xu L, Wald MM, Coronado VG. Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations and Deaths 2002-2006 2010, Atlanta, Georgia, USA: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control.
2. Kuppermann N, Holmes JF, Dayan PS, Hoyle JD, Atabaki SM, Holubkov R, Nadel FM, Monroe D, Stanley RM, Borgialli DA, Badawy MK, Schunk JE, Quayle KS, Mahajan P, Lichenstein R, Lillis KA, Tunik MG, Jacobs ES, Callahan JM, Gorelick MH, Glass TF, Lee LK, Bachman MC, Cooper A, Powell EC, Gerardi MJ, Melville KA, Muizelaar JP, Wisner DH, Zuspan SJ, et al. Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. Lancet 2009, 374:1160-1170. 10.1016/S0140-6736(09)61558-0, 19758692.
3. Pearce MS, Salotti JA, Little MP, McHugh K, Lee C, Kim KP, Howe NL, Ronckers CM, Rajaraman P, Craft AW, Parker L, Berrington de González A. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. Lancet 2012, 380:499-505. 10.1016/S0140-6736(12)60815-0, 3418594, 22681860.
4. Mathews JD, Forsythe AV, Brady Z, Butler MW, Goergen SK, Byrnes GB, Giles GG, Wallace AB, Anderson PR, Guiver TA, McGale P, Cain TM, Dowty JG, Bickerstaffe AC, Darby SC. Cancer risk in 680,000 people exposed to computed tomography scans in childhood or adolescence: data linkage study of 11 million Australians. BMJ 2013, 346:f2360. 10.1136/bmj.f2360, 3660619, 23694687.
5. Smith-Bindman R, Lipson J, Marcus R, Kim KP, Mahesh M, Gould R, Berrington de Gonzalez A, Miglioretti DL. Radiation dose associated with common computed tomography examinations and the associated lifetime attributable risk of cancer. Arch Intern Med 2009, 169(22):2078-2086. 10.1001/archinternmed.2009.427, 20008690.
6. Preston DL, Ron E, Tokuoka S, Funamoto S, Nishi N, Soda M, Mabuchi K, Kodama K. Solid cancer incidence in atomic bomb survivors: 1958-1998. Radiat Res 2007, 168:1-64. 10.1667/RR0763.1, 17722996.
7. McGinn TG, Guyatt GH, Wyer PC, Naylor CD, Stiell IG, Richardson WS. Users' guides to the medical literature: XXII: how to use articles about clinical decision rules: evidence-based medicine working group. JAMA 2000, 284:79-84. 10.1001/jama.284.1.79, 10872017.
8. Schonfeld D, Bressan S, Da Dalt L, Henien MN, Winnett JA, Nigrovic LE. Pediatric emergency care applied research network head injury clinical prediction rules are reliable in practice. Arch Dis Child 2014, 99(5):427-431. 10.1136/archdischild-2013-305004, 24431418.
9. Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango). Soc Sci Med 1997, 44:681-692. 10.1016/S0277-9536(96)00221-3, 9032835.
10. Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2014, 1:CD001431.
11. Karanicolas PJ, Montori VM, Devereaux PJ, Schunemann H, Guyatt GH. A new " mechanistic-practical" framework for designing and interpreting randomized trials. J Clin Epidemiol 2009, 62:479-484. 10.1016/j.jclinepi.2008.02.009, 18468856.
12. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975, 31:103-115. 10.2307/2529712, 1100130.
13. Breslin M, Mullan RJ, Montori VM. The design of a decision aid about diabetes medications for use during the consultation with patients with type 2 diabetes. Patient Educ Couns 2008, 73:465-472. 10.1016/j.pec.2008.07.024, 18771876.
14. Hess EP, Knoedler MA, Shah ND, Kline JA, Breslin M, Branda ME, Pencille LJ, Asplin BR, Nestler DM, Sadosty AT, Stiell IG, Ting HH, Montori VM. The chest pain choice decision aid: a randomized trial. Circ Cardiovasc Qual Outcomes 2012, 5:251-259. 10.1161/CIRCOUTCOMES.111.964791, 22496116.
15. Montori VM, Shah ND, Pencille LJ, Branda ME, Van Houten HK, Swiglo BA, Kesman RL, Tulledge-Scheitel SM, Jaeger TM, Johnson RE, Bartel GA, Melton LJ, Wermers RA. Use of a decision aid to improve treatment decisions in osteoporosis: the osteoporosis choice randomized trial. Am J Med 2011, 124:549-556. 10.1016/j.amjmed.2011.01.013, 21605732.
16. Mullan RJ, Montori VM, Shah ND, Christianson TJ, Bryant SC, Guyatt GH, Perestelo-Perez LI, Stroebel RJ, Yawn BP, Yapuncich V, Breslin MA, Pencille L, Smith SA. The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med 2009, 169:1560-1568.
17. LeBlanc A, Bodde AE, Branda ME, Yost KJ, Herrin J, Williams MD, Shah ND, Houten HV, Ruud KL, Pencille LJ, Montori VM. Translating comparative effectiveness of depression medications into practice by comparing the depression medication choice decision aid to usual care: study protocol for a randomized controlled trial. Trials 2013, 14:127. 10.1186/1745-6215-14-127, 3663744, 23782672.
18. Montori VM, Breslin M, Maleska M, Weymiller AJ. Creating a conversation: insights from the development of a decision aid. PLoS Med 2007, 4:e233. 10.1371/journal.pmed.0040233, 1939861, 17683195.
19. Pediatric Emergency Care Applied Research Network [http://www.pecarn.org], Pediatric Emergency Care Applied Research Network.
20. Degner LF, Sloan JA, Venkatesh P. The control preferences scale. Can J Nurs Res 1997, 29:21-43.
21. Fagerlin A, Zikmund-Fisher BJ, Ubel PA, Jankovic A, Derry HA, Smith DM. Measuring numeracy without a math test: development of the subjective numeracy scale. Med Decis Making 2007, 27:672-680. 10.1177/0272989X07304449, 17641137.
22. Zikmund-Fisher BJ, Smith DM, Ubel PA, Fagerlin A. Validation of the subjective numeracy scale: effects of low numeracy on comprehension of risk communications and utility elicitations. Med Decis Making 2007, 27:663-671. 10.1177/0272989X07303824, 17652180.
23. Elwyn G, Edwards A, Wensing M, Hood K, Atwell C, Grol R. Shared decision making: developing the OPTION scale for measuring patient involvement. Qual Saf Health Care 2003, 12:93-99. 10.1136/qhc.12.2.93, 1743691, 12679504.
24. Elwyn G, Hutchings H, Edwards A, Rapport F, Wensing M, Cheung WY, Grol R. The OPTION scale: measuring the extent that clinicians involve patients in decision-making tasks. Health Expect 2005, 8:34-42. 10.1111/j.1369-7625.2004.00311.x, 15713169.
25. O'Connor AM. Validation of a decisional conflict scale. Med Decis Making 1995, 15:25-30. 10.1177/0272989X9501500105, 7898294.
26. Koedoot N, Molenaar S, Oosterveld P, Bakker P, de Graeff A, Nooy M, Varekamp I, de Haes H. The decisional conflict scale: further validation in two samples of Dutch oncology patients. Patient Educ Couns 2001, 45:187-193. 10.1016/S0738-3991(01)00120-3, 11722854.
27. Anderson LA, Dedrick RF. Development of the trust in physician scale: a measure to assess interpersonal trust in patient-physician relationships. Psychol Rep 1990, 67:1091-1100. 10.2466/pr0.1990.67.3f.1091, 2084735.
28. Thom DH, Ribisl KM, Stewart AL, Luke DA. Further validation and reliability testing of the trust in physician scale: the Stanford trust study physicians. Med Care 1999, 37:510-517. 10.1097/00005650-199905000-00010, 10335753.
29. Hamilton M, Mrazik M, Johnson DW. Incidence of delayed intracranial hemorrhage in children after uncomplicated minor head injuries. Pediatrics 2010, 126:e33-e39. 10.1542/peds.2009-0692, 20566618.
30. Donner A, Klar N. Design and analysis of cluster randomized trials in health research 2000, London: Arnold Publishers.
31. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg 2012, 10:28-55. 10.1016/j.ijsu.2011.10.001, 22036893.
32. Snijders TAB, Bosker R. Multilevel Analysis. An introduction to basic and advanced multilevel modelling 2012, London: Sage Publications Ltd, 2.
33. Fergusson D, Aaron SD, Guyatt G, Hebert P. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ 2002, 325:652-654. 10.1136/bmj.325.7365.652, 1124168, 12242181.