Top

Clinical Orthopaedics and Related Research®

Published in:

Open Access 01-01-2017 | Editorial

Editorial: JBJS, The Bone & Joint Journal, and Clinical Orthopaedics and Related Research Require Prospective Registration of Randomized Clinical Trials—Why Is This Important?

Authors: Seth S. Leopold, MD, Marc Swiontkowski, MD, Fares Haddad, MD

Published in: Clinical Orthopaedics and Related Research® | Issue 1/2017

Excerpt

Randomized clinical trials (RCTs) represent the best study design for minimizing bias when investigating the effectiveness of a form of treatment. RCTs also are the building blocks of systematic reviews and meta-analyses, which allow more generalizable conclusions to be drawn about therapeutic efficacy [1], provided that the trials themselves are well-designed and implemented, and provided that all of the data are available for such analyses. …

Howick J, Chalmers I, Glasziou P, Greenhalgh T, Heneghan C, Liberati A, Moschetti I, Phillips B, Thornton H. The 2011 Oxford CEBM levels of evidence: Introductory document. Available at: http://www.cebm.net/wp-content/uploads/2014/06/CEBM-Levels-of-Evidence-Introduction-2.1.pdf. Accessed 2016 June 21.

Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA. 2003;289:454–465.CrossRefPubMed

Emerson GB, Warme WJ, Wolf FM, Heckman JD, Brand RA, Leopold SS. Testing for the presence of positive-outcome bias in peer review: A randomized controlled trial. Arch Intern Med. 2010;170:1934–1939.CrossRefPubMed

Lièvre M, Ménard J, Bruckert E, Cogneau J, Delahaye F, Giral P, Leitersdorf E, Luc G, Masana L, Moulin P, Passa P, Pouchain D, Siest G. Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility. BMJ. 2001;322:603–605.CrossRefPubMedPubMedCentral

Rosenthal R. The ‘‘file drawer problem’’ and tolerance for null results. Psychol Bull. 1979;86:638–641.CrossRef

Cochrane Methods Bias. Reporting biases. Available at; http://methods.cochrane.org/bias/reporting-biases. Accessed 2016 June 21.

Higgins JPT, Green S. Cochrane Handbook for systematic reviews of interventions, version 5.1.0: including unpublished studies in systematic reviews. Available at: http://handbook.cochrane.org/chapter_10/10_3_2_including_unpublished_studies_in_systematic_reviews.htm. Accessed 2016 June 23.

Hopewell S, McDonald S, Clarke M, Egger M. Grey literature in meta-analyses of randomized trials of health care interventions. Cochrane Database Syst Rev. 2007;2:MR000010.

ClinicalTrials.gov. Available at: https://clinicaltrials.gov. Accessed 2016 June 21.

10.

World Health Organization. International Clinical Trials Registry Platform (ICTRP): Primary registries. Available at: http://www.who.int/ictrp/network/primary/en/. Accessed 2016 June 21.

11.

BioMed Central. ISRCTN registry. Available at: http://www.isrctn.com. Accessed 2016 September 13.

12.

Rifai N, Bossuyt PM, Ioannidis JP, Bray KR, McShane LM, Golub RM, Hooft L. Registering diagnostic and prognostic trials of tests: Is it the right thing to do? Clin Chem. 2014;60:1146–1152.CrossRefPubMed

13.

International Committee of Medical Journal Editors. Clinical trial registration. Available at: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html. Accessed 2016 June 21.

14.

De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB, International Committee of Medical Journal Editors. Clinical trial registration: A statement from the International Committee of Medical Journal Editors. N Engl J Med. 2004;351:1250–1251.

Title: Editorial: JBJS, The Bone & Joint Journal, and Clinical Orthopaedics and Related Research Require Prospective Registration of Randomized Clinical Trials—Why Is This Important?
Authors: Seth S. Leopold, MD
Marc Swiontkowski, MD
Fares Haddad, MD
Publication date: 01-01-2017
Publisher: Springer US
Published in: Clinical Orthopaedics and Related Research® / Issue 1/2017
Print ISSN: 0009-921X
Electronic ISSN: 1528-1132
DOI: https://doi.org/10.1007/s11999-016-5174-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Editorial: JBJS, The Bone & Joint Journal, and Clinical Orthopaedics and Related Research Require Prospective Registration of Randomized Clinical Trials—Why Is This Important?

Excerpt

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Excerpt

Please log in to get access to this content

Other articles of this Issue 1/2017

CORR Insights®: Variations in the Innervation of the Long Head of the Triceps Brachii: A Cadaveric Investigation

Erratum to: Universal Health Coverage in Massachusetts Did Not Change the Trajectory of Arthroplasty Use or Costs

The John N. Insall Award: Do Intraarticular Injections Increase the Risk of Infection After TKA?

Length of Endoprosthetic Reconstruction in Revision Knee Arthroplasty Is Associated With Complications and Reoperations

CORR Insights®: What Differences in Morphologic Features of the Knee Exist Among Patients of Various Races? A Systematic Review

CORR Insights®: Length of Endoprosthetic Reconstruction in Revision Knee Arthroplasty Is Associated With Complications and Reoperations