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http://annals.org/article.aspx?

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.

Criterion 4: Blinding or masking of health care providers


Identify the Risk of Bias
Low or Unclear
research nurses, other study center personnel, investigators and those who analyz
ed the data were blinded to treatment.
Explanation:
The main consideration in determining risk of bias in the context of blinding or
masking of health care providers is whether those providing clinical care to pa
rticipants (e.g., research nurses and doctors) were aware of the intervention th
at each participant was receiving as part of the study. Blinding or masking of h
ealth care providers protects against performance bias, a form of information bi
as. See Chapter 8.11 and Table 8.5a in the Cochrane Handbook for more details.
The Rayman report explicitly states that research nurses and study personnel wer
e blinded to the treatment the participants were receiving. Therefore, the risk
of bias was low.
That said, some might reasonably make a distinction between health care provider
s and study personnel or research nurses. The article does not state whether or
not those responsible for participant healthcare (other aspects of management, c
o-treatments, etc.) were aware of the treatment the participant was receiving. T
herefore, Unclear is also an answer that merits full credit.
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 5: Blinding or masking of outcome assessors for the outcome mean plasma
selenium concentration
Identify the Risk of Bias
Unclear
Explanation:
The main consideration in determining risk of bias in the context of blinding or
masking of outcome assessors is whether those assessing (or measuring) outcomes
(e.g., plasma selenium concentration) were aware of the intervention that each
participant was receiving as part of the study. Blinding or masking of outcome a
ssessors protects against detection bias, a form of information bias. See Chapte
r 8.12 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 plasma selenium concentration. It i
s entirely possible that while these individuals were masked, the lab technician
s who actually measured and documented the plasma selenium levels were not. It i
s also worth noting that a study s data analysts cannot be assumed to be same indi
viduals 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.
Criterion 6: Blinding or masking of outcome assessors for the outcome
nts
Identify the Risk of Bias
Unclear

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.