Cargando…
Is There an Association Between Authors’ Conflicts of Interest and Outcomes in Clinical Studies Involving Autologous Chondrocyte Implantation?
BACKGROUND: Autologous chondrocyte implantation (ACI) is an increasingly popular technique for the treatment of articular cartilage defects. Because several companies have financial interests in ACI, it is important to consider possible conflicts of interest when evaluating studies reporting outcome...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7876765/ https://www.ncbi.nlm.nih.gov/pubmed/33623797 http://dx.doi.org/10.1177/2325967120979988 |
_version_ | 1783650033768333312 |
---|---|
author | Mayo, Benjamin C. Ravella, Krishna C. Onsen, Leonard Bobko, Aimee Schwarzman, Garrett R. Steffes, Matthew J. Miller, Adam Hutchinson, Mark R. |
author_facet | Mayo, Benjamin C. Ravella, Krishna C. Onsen, Leonard Bobko, Aimee Schwarzman, Garrett R. Steffes, Matthew J. Miller, Adam Hutchinson, Mark R. |
author_sort | Mayo, Benjamin C. |
collection | PubMed |
description | BACKGROUND: Autologous chondrocyte implantation (ACI) is an increasingly popular technique for the treatment of articular cartilage defects. Because several companies have financial interests in ACI, it is important to consider possible conflicts of interest when evaluating studies reporting outcomes of ACI. PURPOSE: To determine whether there is an association between authors’ financial conflicts of interest and the outcomes of ACI studies. STUDY DESIGN: Cross-sectional study. METHODS: A search of PubMed and MEDLINE databases for “autologous chondrocyte implantation” was performed. Clinical studies published after 2012 through May 15, 2019, and in English were included. Studies were determined to have financial conflicts of interest if any contributing author had relevant conflicts, either self-reported in the published study’s disclosures section or reported online in the American Academy of Orthopaedic Surgeons Disclosure database or the Centers for Medicare & Medicaid Services Open Payments database. The outcomes of each study were rated as favorable, equivocal, or unfavorable based on predefined criteria and then tested for association with conflicts of interest through use of the Fisher exact test. RESULTS: A total of 79 studies met the inclusion criteria. Nearly all studies were of level 3 or 4 evidence. Conflicts of interest were established in 51.90% of studies (n = 41). Conflicts that were not self-reported by the authors were discovered in 18% of studies. The level of evidence was not associated with conflict of interest. No statistically significant difference was found in the rate of favorable outcomes between studies with conflicts (92.68%) and those with no conflicts (81.58%) (P = .126). Publications by US authors were more likely to have financial conflicts of interest (P = .003). CONCLUSION: Favorable results were reported in a majority of studies involving ACI. No statistical association was found between the frequency of favorable outcomes and the presence of financial conflicts of interest, country of authorship, or level of evidence. There was a trend toward more favorable outcomes in studies with conflicts of interest. Additionally, nearly 20% of publications had possible conflicts found online that were not self-reported. It is critical for orthopaedic surgeons to judiciously evaluate published studies and consider financial conflicts of interest before performing ACI techniques on patients. |
format | Online Article Text |
id | pubmed-7876765 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-78767652021-02-22 Is There an Association Between Authors’ Conflicts of Interest and Outcomes in Clinical Studies Involving Autologous Chondrocyte Implantation? Mayo, Benjamin C. Ravella, Krishna C. Onsen, Leonard Bobko, Aimee Schwarzman, Garrett R. Steffes, Matthew J. Miller, Adam Hutchinson, Mark R. Orthop J Sports Med Article BACKGROUND: Autologous chondrocyte implantation (ACI) is an increasingly popular technique for the treatment of articular cartilage defects. Because several companies have financial interests in ACI, it is important to consider possible conflicts of interest when evaluating studies reporting outcomes of ACI. PURPOSE: To determine whether there is an association between authors’ financial conflicts of interest and the outcomes of ACI studies. STUDY DESIGN: Cross-sectional study. METHODS: A search of PubMed and MEDLINE databases for “autologous chondrocyte implantation” was performed. Clinical studies published after 2012 through May 15, 2019, and in English were included. Studies were determined to have financial conflicts of interest if any contributing author had relevant conflicts, either self-reported in the published study’s disclosures section or reported online in the American Academy of Orthopaedic Surgeons Disclosure database or the Centers for Medicare & Medicaid Services Open Payments database. The outcomes of each study were rated as favorable, equivocal, or unfavorable based on predefined criteria and then tested for association with conflicts of interest through use of the Fisher exact test. RESULTS: A total of 79 studies met the inclusion criteria. Nearly all studies were of level 3 or 4 evidence. Conflicts of interest were established in 51.90% of studies (n = 41). Conflicts that were not self-reported by the authors were discovered in 18% of studies. The level of evidence was not associated with conflict of interest. No statistically significant difference was found in the rate of favorable outcomes between studies with conflicts (92.68%) and those with no conflicts (81.58%) (P = .126). Publications by US authors were more likely to have financial conflicts of interest (P = .003). CONCLUSION: Favorable results were reported in a majority of studies involving ACI. No statistical association was found between the frequency of favorable outcomes and the presence of financial conflicts of interest, country of authorship, or level of evidence. There was a trend toward more favorable outcomes in studies with conflicts of interest. Additionally, nearly 20% of publications had possible conflicts found online that were not self-reported. It is critical for orthopaedic surgeons to judiciously evaluate published studies and consider financial conflicts of interest before performing ACI techniques on patients. SAGE Publications 2021-02-09 /pmc/articles/PMC7876765/ /pubmed/33623797 http://dx.doi.org/10.1177/2325967120979988 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc-nd/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 License (https://creativecommons.org/licenses/by-nc-nd/4.0/) which permits non-commercial use, reproduction and distribution of the work as published without adaptation or alteration, without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Article Mayo, Benjamin C. Ravella, Krishna C. Onsen, Leonard Bobko, Aimee Schwarzman, Garrett R. Steffes, Matthew J. Miller, Adam Hutchinson, Mark R. Is There an Association Between Authors’ Conflicts of Interest and Outcomes in Clinical Studies Involving Autologous Chondrocyte Implantation? |
title | Is There an Association Between Authors’ Conflicts of Interest and
Outcomes in Clinical Studies Involving Autologous Chondrocyte
Implantation? |
title_full | Is There an Association Between Authors’ Conflicts of Interest and
Outcomes in Clinical Studies Involving Autologous Chondrocyte
Implantation? |
title_fullStr | Is There an Association Between Authors’ Conflicts of Interest and
Outcomes in Clinical Studies Involving Autologous Chondrocyte
Implantation? |
title_full_unstemmed | Is There an Association Between Authors’ Conflicts of Interest and
Outcomes in Clinical Studies Involving Autologous Chondrocyte
Implantation? |
title_short | Is There an Association Between Authors’ Conflicts of Interest and
Outcomes in Clinical Studies Involving Autologous Chondrocyte
Implantation? |
title_sort | is there an association between authors’ conflicts of interest and
outcomes in clinical studies involving autologous chondrocyte
implantation? |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7876765/ https://www.ncbi.nlm.nih.gov/pubmed/33623797 http://dx.doi.org/10.1177/2325967120979988 |
work_keys_str_mv | AT mayobenjaminc isthereanassociationbetweenauthorsconflictsofinterestandoutcomesinclinicalstudiesinvolvingautologouschondrocyteimplantation AT ravellakrishnac isthereanassociationbetweenauthorsconflictsofinterestandoutcomesinclinicalstudiesinvolvingautologouschondrocyteimplantation AT onsenleonard isthereanassociationbetweenauthorsconflictsofinterestandoutcomesinclinicalstudiesinvolvingautologouschondrocyteimplantation AT bobkoaimee isthereanassociationbetweenauthorsconflictsofinterestandoutcomesinclinicalstudiesinvolvingautologouschondrocyteimplantation AT schwarzmangarrettr isthereanassociationbetweenauthorsconflictsofinterestandoutcomesinclinicalstudiesinvolvingautologouschondrocyteimplantation AT steffesmatthewj isthereanassociationbetweenauthorsconflictsofinterestandoutcomesinclinicalstudiesinvolvingautologouschondrocyteimplantation AT milleradam isthereanassociationbetweenauthorsconflictsofinterestandoutcomesinclinicalstudiesinvolvingautologouschondrocyteimplantation AT hutchinsonmarkr isthereanassociationbetweenauthorsconflictsofinterestandoutcomesinclinicalstudiesinvolvingautologouschondrocyteimplantation |