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Management of financial conflicts of interests in clinical practice guidelines in Germany: results from the public database GuidelineWatch
BACKGROUND: The reliability of clinical practice guidelines has been disputed because guideline panel members are often burdened with financial conflicts of interest (COI). Current recommendations for COI regulation advise not only detailed declaration but also active management of conflicts. To con...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6022410/ https://www.ncbi.nlm.nih.gov/pubmed/29954379 http://dx.doi.org/10.1186/s12910-018-0309-y |
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author | Napierala, Hendrik Schäfer, Luise Schott, Gisela Schurig, Niklas Lempert, Thomas |
author_facet | Napierala, Hendrik Schäfer, Luise Schott, Gisela Schurig, Niklas Lempert, Thomas |
author_sort | Napierala, Hendrik |
collection | PubMed |
description | BACKGROUND: The reliability of clinical practice guidelines has been disputed because guideline panel members are often burdened with financial conflicts of interest (COI). Current recommendations for COI regulation advise not only detailed declaration but also active management of conflicts. To continuously assess COI declaration and management in German guidelines we established the public database LeitlinienWatch (GuidelineWatch). METHODS: We analyzed all German guidelines at the highest methodological level (S3) that included recommendations for pharmacological therapy (n = 67) according to five criteria: declaration and assessment of COI, composition of the guideline development group, independence of the coordinators and lead authors, imposed abstentions because of COI and public external review. Each criterion was assessed using predefined outcome categories. RESULTS: Most guidelines (76%) contained a detailed declaration of COI. However, none of the guidelines provided full transparency of COI assessment results. The guideline group was composed of a majority of participants with COI in 55% of the guidelines, no guideline was free of participants with COI. Only 9% of guidelines had coordinators and lead authors without any financial COI. Most guidelines (70%) did not provide a rule for abstentions for participants with COI. In 21% of guidelines there was a rule, but abstentions were either not practiced or not documented, whereas in 7% partial abstentions and in 2% complete abstentions were documented. Two thirds of the guideline drafts (67%) were not externally reviewed via a public website. CONCLUSIONS: COI are usually documented in detail in German guidelines of the highest methodological level. However, considerable improvement is needed regarding active management of COI, including recruitment of independent experts for guideline projects, abstention from voting for participants with COI and external review of the guideline draft. We assume that the publicly available ratings on GuidelineWatch will improve the handling of conflicts of interest in guideline development. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12910-018-0309-y) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6022410 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-60224102018-07-09 Management of financial conflicts of interests in clinical practice guidelines in Germany: results from the public database GuidelineWatch Napierala, Hendrik Schäfer, Luise Schott, Gisela Schurig, Niklas Lempert, Thomas BMC Med Ethics Research Article BACKGROUND: The reliability of clinical practice guidelines has been disputed because guideline panel members are often burdened with financial conflicts of interest (COI). Current recommendations for COI regulation advise not only detailed declaration but also active management of conflicts. To continuously assess COI declaration and management in German guidelines we established the public database LeitlinienWatch (GuidelineWatch). METHODS: We analyzed all German guidelines at the highest methodological level (S3) that included recommendations for pharmacological therapy (n = 67) according to five criteria: declaration and assessment of COI, composition of the guideline development group, independence of the coordinators and lead authors, imposed abstentions because of COI and public external review. Each criterion was assessed using predefined outcome categories. RESULTS: Most guidelines (76%) contained a detailed declaration of COI. However, none of the guidelines provided full transparency of COI assessment results. The guideline group was composed of a majority of participants with COI in 55% of the guidelines, no guideline was free of participants with COI. Only 9% of guidelines had coordinators and lead authors without any financial COI. Most guidelines (70%) did not provide a rule for abstentions for participants with COI. In 21% of guidelines there was a rule, but abstentions were either not practiced or not documented, whereas in 7% partial abstentions and in 2% complete abstentions were documented. Two thirds of the guideline drafts (67%) were not externally reviewed via a public website. CONCLUSIONS: COI are usually documented in detail in German guidelines of the highest methodological level. However, considerable improvement is needed regarding active management of COI, including recruitment of independent experts for guideline projects, abstention from voting for participants with COI and external review of the guideline draft. We assume that the publicly available ratings on GuidelineWatch will improve the handling of conflicts of interest in guideline development. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12910-018-0309-y) contains supplementary material, which is available to authorized users. BioMed Central 2018-06-28 /pmc/articles/PMC6022410/ /pubmed/29954379 http://dx.doi.org/10.1186/s12910-018-0309-y Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Article Napierala, Hendrik Schäfer, Luise Schott, Gisela Schurig, Niklas Lempert, Thomas Management of financial conflicts of interests in clinical practice guidelines in Germany: results from the public database GuidelineWatch |
title | Management of financial conflicts of interests in clinical practice guidelines in Germany: results from the public database GuidelineWatch |
title_full | Management of financial conflicts of interests in clinical practice guidelines in Germany: results from the public database GuidelineWatch |
title_fullStr | Management of financial conflicts of interests in clinical practice guidelines in Germany: results from the public database GuidelineWatch |
title_full_unstemmed | Management of financial conflicts of interests in clinical practice guidelines in Germany: results from the public database GuidelineWatch |
title_short | Management of financial conflicts of interests in clinical practice guidelines in Germany: results from the public database GuidelineWatch |
title_sort | management of financial conflicts of interests in clinical practice guidelines in germany: results from the public database guidelinewatch |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6022410/ https://www.ncbi.nlm.nih.gov/pubmed/29954379 http://dx.doi.org/10.1186/s12910-018-0309-y |
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