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articleid=1767855
What is the rationale of having two or more individuals complete the systematic
review-related tasks of title and abstract screening, data abstraction, and risk
of bias assessment?
Meta-bias
Reduce/minimize errors
Reduce/minimize (any or all of the following): selection bias, information bias,
bias in the analysis
Improve reproducibility, reliability, validity, and quality of systematic review
s
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0045269
Criterion 1: Sequence generation
Identify the Risk of Bias
Low
"Computer-generated random permuted blocks"
Criterion 2: Allocation concealment
Identify the Risk of Bias
Unclear or Low
Explanation:
The main consideration in determining risk of bias in the context of allocation
concealment is whether or not those responsible for implementing the schedule of
random assignment could foresee in advance the forthcoming intervention assignm
ent. Allocation concealment protects against selection bias. See Chapter 8.10 an
d Table 8.5a in the Cochrane Handbook for more details.
In the Rayman report, the authors describe the generation of a random sequence (
they state that computer-generated random permuted blocks were carried out at the
Clinical Trials and Statistics Unit, Institute of Cancer Research, Sutton Surre
y, UK ). However, nothing is mentioned about whether this random sequence, once ge
nerated, was adequately concealed to the study personnel who assign participants
to the treatment groups. If the random sequence were revealed to the study pers
onnel in advance of assigning a participant to his/her respective treatment grou
p, the risk of bias would be high. If the participating sites had to call in to
the Clinical Trials and Statistics Unit to obtain the assignment right before ea
ch participant was randomized, the risk of bias would be low. However, given tha
t the article did not provide this information, the risk of bias is unclear.
That said, we understand that some might make the assumption that because the se
quence was generated at the Clinical Trials and Statistics Unit (a separate loca
tion from the participant recruitment sites), those recruiting participants were
likely unaware of the randomization sequence. We think this assumption is not t
he most appropriate based on information presented in the article. Therefore, a
determination of low risk of bias for allocation concealment merits partial cred
it.
We also understand that some learners may have used the protocol. In real life s
ystematic reviews, we encourage you to seek out all sources of information for a
trial, especially when information in a publication is unclear or data are miss
ing. However, in the interest of making this assignment not too burdensome for e
verybody, we asked that you base your answers only on text available in the arti
cle. Accordingly, this rubric is focused more on information presented in the ar
ticle.
Criterion 3: Blinding or masking of participants
Identify the Risk of Bias
Low
Participants, research nurses, other study center personnel, investigators and th
ose who analyzed the data were blinded to treatment.
adverse eve
Explanation:
As above, the main consideration in determining risk of bias in the context of b
linding or masking of outcome assessors is whether those assessing (or measuring
) outcomes (e.g., adverse events) were aware of the intervention that each parti
cipant was receiving as part of the study. Blinding or masking of outcome assess
ors protects against detection bias, a form of information bias. See Chapter 8.1
2 and Table 8.5a in the Cochrane Handbook for more details.
The Rayman report does not make any mention of outcome assessors being blinded,
and therefore the risk of bias is Unclear. The authors tell us that the research
nurses, other study personnel, investigators, and those who analyzed the data w
ere masked, but it is inappropriate to assume that any of these groups of indivi
duals also evaluated the outcomes, including adverse events. It is entirely poss
ible that while these individuals were masked, a separate set of individuals doc
umented the adverse events, or perhaps, the adverse events were self-reported by
patients. Again, it is worth noting that a study s data analysts cannot be assume
d to be same individuals who assess the outcomes.
We also understand that some learners may have used the protocol. In real life s
ystematic reviews, we encourage you to seek out all sources of information for a
trial, especially when information in a publication is unclear or data are miss
ing. However, in the interest of making this assignment not too burdensome for e
verybody, we asked that you base your answers only on text available in the arti
cle. Accordingly, this rubric is focused more on information presented in the ar
ticle.