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<p>Read the COMPare papers:</p>
<ul>
<li><a href="https://doi.org/10.1186/s13063-019-3173-2">A prospective cohort study correcting and monitoring 58 misreported trials in real time</a></li>
<li><a href="https://doi.org/10.1186/s13063-019-3172-3">Qualitative analysis of researchers’ responses to critical correspondence on a cohort of 58 misreported trials</a></li>
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</h1>
<h2 class="site-description" itemprop="description">
Tracking switched outcomes in clinical trials
</h2>
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<h1 class="entry-title" itemprop="headline">FAQ</h1>
</header>
<div class="entry-content" itemprop="text">
<p>
<span style="color: #000000"
><strong><i>How is COMPare funded?</i></strong></span
>
</p>
<p>
<span style="font-weight: 400; color: #000000"
>No specific funding has been sought for COMPare. The PI Ben
Goldacre receives academic funding from the
<a href="https://www.arnoldventures.org/"
>Laura and John Arnold Foundation</a
>
to do work in the field of scientific integrity. The other
two supervisors, Kamal Mahtani and Carl Heneghan, are funded
by teaching and other small non-industry grants. The
majority of the analysis and coding is currently done by 5
medical students at the University of Oxford, who work for
free.
</span>
</p>
<p>
<span style="color: #000000"
><strong
><i
>Don’t journals already check for outcome switching?</i
></strong
></span
>
</p>
<p>
<span style="font-weight: 400; color: #000000"
>Journals generally say that they do, but our findings
– and those from previous work on the subject –
show that they do not.</span
>
</p>
<p>
<span style="color: #000000"
><strong><i>Are you publishing on this?</i></strong></span
>
</p>
<p>
<span style="font-weight: 400; color: #000000"
>Yes, we are currently submitting a series of academic
journal publications on the quantitative and qualitative
data we have collected.
</span>
</p>
<p>
<span style="color: #000000"
><strong
><i
>There are often legitimate reasons for changing
outcomes during a trial. Does COMPare consider this
“outcome switching”?</i
></strong
></span
>
</p>
<p>
<span style="font-weight: 400; color: #000000"
>No. We agree that outcomes can change for good reasons
after a trial has started. However, consistent with the
<a href="https://www.consort-statement.org/"
>CONSORT guidelines</a
>, these changes must be declared and explained in the trial
report. Where changes have been declared, we consider the
outcomes in that trial to be correctly reported.
</span>
</p>
<p>
<span style="color: #000000"
><strong
><i
>Where do you get the information on pre-specified
outcomes?</i
></strong
></span
>
</p>
<p>
<span style="font-weight: 400; color: #000000"
><a href="wp-content/uploads/2016/01/protocol.pdf"
>Our gold standard</a
>
for finding pre-specified outcomes is a trial protocol that
pre-dates trial commencement, as this is where CONSORT
states outcomes should be pre-specified. However this is
often not available, in which case, as a second best, we get
the pre-specified outcomes from the trial registry entry
that pre-dates the trial commencement. Where the registry
entry has been modified since the trial began, we access the
archived versions, and take the pre-specified outcomes from
the last registry entry before the trial began. As in the
previous FAQ point, consistent with CONSORT, if such changes
are made after the start of the trial, but they are
discussed and declared in the paper, then we consider the
outcomes in the trial to be correctly reported. If there is
no registry entry or protocol from before the trial began,
then there are no pre-specified outcomes at all.
</span>
</p>
<p>
<span style="color: #000000"
><strong
><i
>On one of your assessments, you score outcomes as
“non-prespecified”, however they are declared in the
protocol published with the trial. Why did you not
consider this protocol when assessing the trial?</i
></strong
></span
>
</p>
<p>
<span style="color: #000000"
><span style="font-weight: 400"
>If the protocol was published </span
><i
><span style="font-weight: 400"
>after trial commencement</span
></i
><span style="font-weight: 400"
>, it cannot, by definition, contain </span
><i><span style="font-weight: 400">pre-specified</span></i
><span style="font-weight: 400">
outcomes. If the outcomes in this protocol differ from
those originally specified before the trial, then these
changes must be declared in the publication reporting the
trial results.</span
></span
>
</p>
<p>
<span style="color: #000000"
><strong
><i
>Trial protocols are often updated and published after
trial commencement, for good reasons. Do you take into
account protocol amendments when assessing outcome
reporting?</i
></strong
></span
>
</p>
<p>
<span style="color: #000000"
><span style="font-weight: 400"
>Protocols published after the trial start date cannot, by
definition, contain </span
><i><span style="font-weight: 400">pre-specified</span></i
><span style="font-weight: 400">
outcomes. We regard changes to pre-specified outcomes as
completely normal, however they must be declared in the
publication reporting the trial results. Where updates or
amendments to the original outcomes have been declared, we
consider the outcomes in that trial to be correctly
reported.
</span></span
>
</p>
<p>
<span style="color: #000000"
><strong
><i
>What if some outcomes are reported in a different
publication?</i
></strong
></span
>
</p>
<p>
<span style="font-weight: 400; color: #000000"
>This is fine, as long as this fact has been declared in the
trial publication. For example, if a trial says “here we are
reporting A B and C, in a subsequent paper we will report X
Y Z” then the outcomes X Y Z are not considered as
unreported, and they are removed from the denominator.
</span>
</p>
<p>
<span style="color: #000000"
><strong><i>What’s next?</i></strong></span
>
</p>
<p>
<span style="font-weight: 400; color: #000000"
>Phase one of our project was writing the correction
letters. We are now moving on to phase two: discussing
journals’ responses, and publishing commentary on specific
aspects of coding individual trials, to illustrate the
mechanics of misreporting by using concrete examples.
</span>
</p>
<p>
<span style="color: #000000"
><strong><i>Where are your data?</i></strong></span
>
</p>
<p>
<span style="font-weight: 400; color: #000000"
>We take an “open lab books”, “open science” approach. All
of our data are shared in full on this site, including our
internal coding sheets that list all the pre-specified
outcomes, the presence or absence of each pre-specified
outcome in the trial report, and the novel non-pre-specified
outcomes. We are also openly sharing responses from
journals, and our responses back to them.
</span>
</p>
<p>
<span style="color: #000000"
><strong
><i>This is a huge amount of work!</i></strong
></span
>
</p>
<p>
<span style="font-weight: 400; color: #000000"
>Yes it is. It takes several hours on average to obtain the
pre-specified outcomes, and then compare them against each
trial report. We believe this work could be done more
efficiently, and should be done, by journals themselves.
</span>
</p>
<p>
<span style="color: #000000"
><strong
><i
>I disagree with your coding of my trial! Can I tell you
why, or comment on it?</i
></strong
></span
>
</p>
<p>
<span style="color: #000000"
><span style="font-weight: 400"
>We will happily correct any errors, please email </span
><span style="color: #0000ff"
><a
style="color: #0000ff"
href="mailto:[email protected]"
><span style="font-weight: 400"
>[email protected]</span
></a
></span
><span style="font-weight: 400">
and do bear in mind the FAQ issues above. We will gladly
publish comments about coding or journal responses on our
blog. However please do bear in mind the following: we
have set out to correct the record on incorrect outcome
reporting through correction letters to the journal that
printed the error. This is to ensure that those using the
results of trials to inform their own clinical decision
making and research are able to access information on the
reporting error. We therefore think it is most appropriate
that informed discussion on individual trials switching
their pre-specified outcomes should take place in the
pages of the journal that published the trial.
</span></span
>
</p>
<p>
<span style="color: #000000"
><strong><i>Can I help?</i></strong></span
><br />
<span style="color: #000000">
<span style="font-weight: 400"
>Yes, by raising awareness of outcome switching, and
individual trials that have misreported their outcomes;
and by working within your field to reduce the prevalence
of the problem, by supporting CONSORT and other
initiatives. We are currently considering how best to
expand the model. In particular we are interested in
working with other groups who want to “own” a series of
journals, for example in their own medical specialty.
Please do get in touch if you are interested.
<span style="color: #0000ff"> </span></span
><span style="color: #0000ff"
><a
style="color: #0000ff"
href="mailto:[email protected]"
><span style="font-weight: 400"
>[email protected]</span
></a
></span
></span
>
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<h4 class="widget-title widgettitle">How to cite us</h4>
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<p>
Prior to publication of the first paper on COMPare, please
cite this project as:
</p>
<p>
<em>The COMPare Trials Project.</em> Goldacre B, Drysdale H,
Powell-Smith A, et al. www.COMPare-trials.org, 2016.
</p>
<p>Or alternatively:</p>
<p>
<em>The COMPare Trials Project.</em> Ben Goldacre, Henry
Drysdale, Anna Powell-Smith, Aaron Dale, Ioan Milosevic,
Eirion Slade, Philip Hartley, Cicely Marston, Kamal Mahtani,
Carl Heneghan. www.COMPare-trials.org, 2016.
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