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2018 ; 19
(1
): 65
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English Wikipedia
Management of financial conflicts of interests in clinical practice guidelines in
Germany: results from the public database GuidelineWatch
#MMPMID29954379
Napierala H
; Schäfer L
; Schott G
; Schurig N
; Lempert T
BMC Med Ethics
2018[Jun]; 19
(1
): 65
PMID29954379
show ga
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.