Shoulder Arthroplasty Trials Are Infrequently Registered: A Systematic Review of Trials

INTRODUCTION: With the intent of improving transparency in clinical research, the International Committee of Medical Journal Editors (ICMJE) established guidelines in 2005 regarding prospective clinical trial registration. This action worked to address bias related to selective outcome reporting in the medical literature. The objective of this study was to assess and characterize the quality of registration of clinical trials appearing in shoulder arthroplasty-related medical journals. METHODS: All randomized trials involving human subjects, pertaining to shoulder arthroplasty, published between July 1, 2005 and December 31, 2015, and indexed in either PubMed or SportDISCUS were analyzed. We assessed the prevalence of registration, the timing of registration relative to patient enrollment periods, and the variable rates of orthopedic journal compliance with ICMJE and Food and Drug Administration clinical registration standards for our study. RESULTS: Of the 382 articles identified, 345 (90.3%) were excluded due to failure to meet inclusion criteria. From the remaining 37, only 12 (32.4%) studies were found to be registered in a trial registry. Ten (10/12, 83.3%) of these provided their registration information within the body of the article. None of the included studies from ICMJE-recognized journals were registered. From 34 included studies from non-ICMJE recognized journals, 12 (35.3%) were registered. CONCLUSION: The level of compliance with clinical trial registration guidelines in the decade since their release among shoulder arthroplasty trials in orthopedic journals is poor. Given the importance of the issue, the prevalence of the problem, and the fact that many other medical specialties have already made efforts to improve ICMJE compliance, further work on the part of orthopedic surgery journal authors and editors is needed to ensure the publication of unbiased results. TRIAL REGISTRATION: UMIN000022487.

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PID https://www.doi.org/10.1371/journal.pone.0164984
PID pmc:PMC5072652
PID pmid:27764210
URL https://paperity.org/p/80220131/shoulder-arthroplasty-trials-are-infrequently-registered-a-systematic-review-of-trials
URL http://dx.doi.org/10.1371/journal.pone.0164984
URL http://europepmc.org/articles/PMC5072652?pdf=render
URL https://dx.plos.org/10.1371/journal.pone.0164984
URL https://scholars.okstate.edu/en/publications/shoulder-arthroplasty-trials-are-infrequently-registered-a-system
URL http://europepmc.org/articles/PMC5072652
URL https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0164984&type=printable
URL https://www.ncbi.nlm.nih.gov/pubmed/27764210
URL http://dx.plos.org/10.1371/journal.pone.0164984
URL https://academic.microsoft.com/#/detail/2532712064
URL https://dx.doi.org/10.1371/journal.pone.0164984
URL https://doaj.org/toc/1932-6203
URL https://core.ac.uk/display/149818279
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Author Ben Matthew Vassar, 0000-0003-2859-6152
Author Matthew Sims, 0000-0001-8430-1983
Contributor Reilly, Gwendolen
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Collected From Europe PubMed Central; PubMed Central; ORCID; Datacite; UnpayWall; DOAJ-Articles; Crossref; Microsoft Academic Graph
Hosted By Europe PubMed Central; PLoS ONE
Publication Date 2016-10-20
Publisher Public Library of Science (PLoS)
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Resource Type Other literature type; Article; UNKNOWN
keyword Q
keyword R
keyword keywords.General Biochemistry, Genetics and Molecular Biology
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Source https://science-innovation-policy.openaire.eu/search/publication?articleId=dedup_wf_001::3f518c8ac7f2a1a96d25e47666853736
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Last Updated 21 December 2020, 20:48 (CET)
Created 21 December 2020, 20:48 (CET)