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2017 ; 17
(ä): 3
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The risk of bias in randomized controlled trials in otorhinolaryngology: hardly
any improvement since 1950
#MMPMID28428729
Peters JPM
; Stegeman I
; Grolman W
; Hooft L
BMC Ear Nose Throat Disord
2017[]; 17
(ä): 3
PMID28428729
show ga
BACKGROUND: Randomized Controlled Trials (RCTs) represent the most valuable study
design to evaluate the effectiveness of therapeutic interventions. However, flaws
in design, conduct, analysis, and reporting of RCTs can cause the effect of an
intervention to be under- or overestimated. These biased RCTs may be included in
literature reviews. To make the assessment of Risk of Bias (RoB) consistent and
transparent, Cochrane published a RoB tool, with which RoB is assessed per item
as "low", "unclear" or "high". Our objective was to provide an overview of RoB
assessments of RCTs in otorhinolaryngology over time, and to identify items where
improvement is still warranted. METHODS: We retrieved Cochrane reviews in the
otorhinolaryngologic research field published in 2012 and 2013. We used all
judgments per item as assessed by the review authors of the included RCTs. We
evaluated the association between "low RoB" vs. "unclear and high RoB" and the
year of publication (time strata: '<1990', '1990-1995', '1996-2000', '2001-2005',
'2006-2012') per item using binary logistic regression. RESULTS: We extracted the
RoB assessments from 42 Cochrane reviews that had included 402 RCTs (median
number of RCTs per review: 7, range 1-40). In total 2,356 items were assessed
(mean number of assessed items per RCT: 5.9, standard deviation 1.8). On binary
logistic regression, RCTs published in 2006-2012, compared with those published
before 1990, were more likely to have a low RoB for two items: random sequence
generation (odds ratio 6.09 [95% confidence interval: 3.11-11.95]) and allocation
concealment (3.59 [1.87-6.90]). On all other items, there was no significant
increase in the proportion of low RoB when comparing RCTs published in 2006-2012
with RCTs published before 1990. CONCLUSION: Although there were some positive
developments in the RoB assessments in otorhinolaryngology, a further decrease in
RoB is still warranted on several items. Currently, biased RCTs are included in
Cochrane reviews and effects of therapeutic interventions can be under- or
overestimated, with implications for clinical patient care.