The quality of randomized controlled trials in pediatric orthopaedics: Are we improving?

Journal of Pediatric Orthopaedics

Volumn 35, Issue 5, 2014, Pages 536-545

  Dodwell, Emily ^a   Dua, Shiv ^b   Dulai, Sukhdeep K ^c   Astone, Kristina ^a   Mulpuri, Kishore ^d  

^a HOSPITAL FOR SPECIAL SURGERY   (United States)

^b GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES   (United States)

^c STOLLERY CHILDREN S HOSPITAL   (Canada)

^d UNIVERSITY OF BRITISH COLUMBIA   (Canada)

Author keywords

CONSORT; Detsky; Quality; RCT

Indexed keywords

ARTICLE; CLINICAL RESEARCH; CONSORT CHECKLIST; DETSKY QUALITY ASSESSMENT SCALE; ORTHOPEDIC SURGEON; ORTHOPEDICS; POWER ANALYSIS; PRIORITY JOURNAL; PUBLICATION; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGRESSION ANALYSIS; SAMPLE SIZE; BIBLIOMETRICS; CHECKLIST; CHILD; HUMAN; NEEDS ASSESSMENT; PEDIATRICS; PROCEDURES; STANDARDS; TOTAL QUALITY MANAGEMENT;

BIBLIOMETRICS; CHECKLIST; CHILD; HUMANS; NEEDS ASSESSMENT; ORTHOPEDICS; PEDIATRICS; QUALITY IMPROVEMENT; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SAMPLE SIZE;

EID: 84916910881     PISSN: 02716798     EISSN: 15392570     Source Type: Journal    
DOI: 10.1097/BPO.0000000000000324     Document Type: Article

References (35)

1. McLeod RS. Issues in surgical randomized controlled trials. World J Surg. 1999;23:1210-1214.
2. Slim K. Limits of evidence-based surgery. World J Surg. 2005;29:606-609.
3. Devereaux PJ, McKee MD, Yusuf S. Methodologic issues in randomized controlled trials of surgical interventions. Clin Orthop Relat Res. 2003;413:25-32.
4. Li P, Mah D, Lim K, et al. Randomization and concealment in surgical trials: a comparison between orthopaedic and non-orthopaedic randomized trials. Arch Orthop Trauma Surg. 2005;125:70-72.
5. Poolman RW, Struijs PA, Krips R, et al. Reporting of outcomes in orthopaedic randomized trials: does blinding of outcome assessors matter? J Bone Joint Surg Am. 2007;89:550-558.
6. Juni P, Altman DG, Eggar M. Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ. 2001;323:42-46.
7. Day SJ, Altman DG. Statistics notes: blinding in clinical trials and other studies. BMJ. 2000;321:504.
8. Schulz KF, Grimes DA. Blinding in randomized trials: hiding who got what. Lancet. 2002;359:696-700.
9. Dulai SK, Slobogean BL, Beauchamp RD, et al. A quality assessment of randomized clinical trials in pediatric orthopaedics. J Pediatr Orthop. 2007;27:573-581.
10. Gummesson C, Atroshi I, Ekdahl C. The quality of reporting and outcome measures in randomized clinical trials related to upper-extremity disorders. J Hand Surg Am. 2004;29:727-734; discussion 735-7.
11. Bailey CS, Fisher CG, Dvorak MF. Type II error in the spine surgical literature. Spine. 2007;32:S15-S19.
12. Bhandari M, Richards RR, Sprague S, et al. The quality of reporting of randomized trials in the journal of bone and joint surgery from 1988 through 2000. J Bone Joint Surg Am. 2002;84-A:388-396.
13. Dodwell E, Reilly C, Fisher CG, et al. Quality of randomized controlled trials in the spine literature. Las Vegas, NV: American Academy of Orthopedic Surgeons Annual Meeting. 2009.
14. Chess LE, Gagnier J. Risk of bias of randomized controlled trials published in orthopaedic journals. BMC Med Res Methodol. 2013;13:76.
15. Detsky AS, Naylor CD, O'Rourke K, et al. Incorporating variations in the quality of individual randomized trials into meta-analysis. J Clin Epidemiol. 1992;45:255-265.
16. Schulz KF, Altman DG, Moher D. For the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.
17. Resnick DK. Evidence-based spine surgery. Spine (Phila Pa 1976). 2007;32(suppl):S15-S19.
18. Poolman RW, Struijs PA, Krips R, et al. Does a "level I evidence" rating imply high quality of reporting in orthopaedic randomised controlled trials? BMC Med Res Methodol. 2006;6:44.
19. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276:637-639.
20. Ghimire S, Kyung E, Kang W, et al. Assessment of adherence to the CONSORT statement for quality of reports on randomized controlled trial abstracts from four high-impact general medical journals. Trials. 2012;13:77.
21. Arneja S, McConkey MO, Mulpuri K, et al. Graft tensioning in anterior cruciate ligament reconstruction: a systematic review of randomized controlled trials. Arthroscopy. 2009;25:200-207.
22. Cashin MS, Kelley SP, Douziech JR, et al. The levels of evidence in pediatric orthopaedic journals: where are we now? J Pediatr Orthop. 2011;31:721-725.
23. Harris JD, Erickson BJ, Abrams GD, et al. Methodologic quality of knee articular cartilage studies. Arthroscopy. 2013;29:1243.e5-1252.e5.
24. Naunheim MR, Walcott BP, Nahed BV, et al. The quality of randomized controlled trial reporting in spine literature. Spine (Phila Pa 1976). 2011;36:1326-1330.
25. Parsons NR, Hiskens R, Price CL, et al. A systematic survey of the quality of research reporting in general orthopaedic journals. J Bone Joint Surg Br. 2011;93:1154-1159.
26. Pike J, Leith J. Type II error in the shoulder and elbow literature. J Shoulder Elbow Surg. 2009;18:44-51.
27. Boutron I, Moher D, Tugwell P, et al. A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus. J Clin Epidemiol. 2005;58:1233-1240.
28. Moher D, Jones A, Lepage L, CONSORT Group (Consolidated Standards for Reporting of Trials). Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA. 2001;285:1992-1995.
29. Plint AC, Moher D, Morrison A, et al. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust. 2006;185:263-267.
30. Chan S, Bhandari M. The quality of reporting of orthopaedic randomized trials with use of a checklist for nonpharmacological therapies. J Bone Joint Surg Am. 2007;89:1970-1978.
31. Hopewell S, Ravaud P, Baron G, et al. Effect of editors' implementation of CONSORT guidelines on the reporting of abstracts in high impact medical journals: Interrupted time series analysis. BMJ. 2012;344:e4178.
32. Devereaux PJ, Choi PT, El-Dika S, et al. An observational study found that authors of randomized controlled trials frequently use concealment of randomization and blinding, despite the failure to report these methods. J Clin Epidemiol. 2004;57:1232-1236.
33. Wright JG, Gebhardt MC. Multicenter clinical trials in orthopaedics: time for musculoskeletal specialty societies to take action. J Bone Joint Surg Am. 2005;87:214-217.
34. Olivo SA, Macedo LG, Gadotti IC, et al. Scales to assess the quality of randomized controlled trials: a systematic review. Phys Ther. 2008;88:156-175.
35. Pietrobon R, Shah AN. Complications of evaluating the scientific quality of randomized clinical trials. J Bone Joint Surg Am. 2002;84-A:2307-2308.