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Undue influence on the PACE Trial outcome?
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As mentioned above, the PACE Trial staff produce participants’ newsletters. One reason why a research
team might include participants’ newsletters in their study design is to encourage participants to remain
within the project. This might be especially useful when long‐term follow‐up is an aspect of a trial.
Newsletters aimed at offering general information to trial participants are not unknown (Blanton S et al.
Physical Therapy 2006:86:11:1520‐1533) but the PACE Trial Newsletters go further than simply providing
general information.
From the first issue (June 2006), PACE Trial participants were urged to send “any feedback on any aspect of the
study”.
The same issue says: “We have already received some informal feedback on the experience of participating in the
study. Comments so far received have included: ‘I really think it is good to be part of something that will make a
difference to so many people’. ‘ We need this research to know the best treatments’. ‘The staff were so professional that
I felt well taken care of’ ”. It also says: “Our website is intended to keep all our participants up to date on the trial.
We would love to hear what you think of it”.
The second Participants’ Newsletter (March 2007) says: “In our last newsletter we asked for feedback and for
contributions from participants and we can happily report that we have received both. Many thanks to those of you
who contacted us…and a special thanks to G.T.Buchan who sent us the poems printed overleaf. Any similar
contribution from participants who are receiving any of the trial treatments will be gratefully received”.
The poems were full of praise for the PACE Trial.
Issue 3 of the Participants’ Newsletter (December 2008) said: “We would love to hear more of your feedback and
see more contributions to this newsletter from participants of PACE”. The same issue contained six glowing
reports of the trial from participants (eg. “The therapy was excellent”; “(The treatment) is now a way of life
for me”; “(The therapist) is very helpful and gives me very useful advice and also motivates me”; “Found
(the treatment) extremely useful”), together with “A doctor’s feedback” from the doctor of a patient
attending the Bristol PACE Trial centre, which says:”I just wanted to feed back to you positive changes I
have seen in (patient X) since participating in your trial. I know the therapy is recommended…for CFS, but
this is the first time I have seen such a well thought out programme put into practice…I would strongly
support any extension of the trial, which clearly has the potential to transform the lives of many people
suffering with this debilitating disease. Congratulations to yourself and your colleagues in such a
successful programme”.
No adverse comments were published in the Participants’ Newsletters.
Providing participants with adequate information is obligatory, but exposing participants or potential
participants to selected opinions of other participants (and of a doctor) is uncalled for in an on‐going trial.
Inviting and publishing letters of praise for a clinical trial that is not yet complete might be deemed
unethical and might even invalidate the whole trial.
If, for example, those people who had written in such glowing terms at the start of the interventions
subsequently knew they had not in fact improved at the end of the trial, they would be unlikely to admit so
in the subjective questionnaire which is intended to inform the outcome, as the published letters would
surely influence those participants’ subsequent answers to their outcome questionnaires.
For trial participants to be praising the trial during a research project ought to invalidate their own data.
Giving participants information that could influence the data they themselves provide – by exposing them
to the selected opinion of other participants – might be viewed as publishing selective data from the trial