Dear Stefan,
It sounds to me that "clinically proven" probably means that your partners
are convinced to deliver good quality care to their patients. Do you know
what the endpoints are they consider to be (most) relevant for quality in
this setting? Have these been formally assessed and compared to an
alternative?
Assuming that this has not happened, I would not see an ethical issue here.
In any case you will have to go to an ethics committe for this study anyway.
Best regards,
Klaus Hieke
NEOS Health AG
Rheinfelden/Switzerland
Tel.: +41 61 8369808
Mobile: +49 170 9067797
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[mailto:[log in to unmask]]Im Auftrag von Stefan
Hebenstreit
Gesendet: Freitag, 17. November 2000 13:58
An: [log in to unmask]
Betreff: ethical question regarding RCTs
Dear all,
I would welcome any advice from the members of this list regarding a
question I consider crucial in the design of a planned study.
Together with partners we are planning a study regarding the
cost-effectiveness of a hospital-based transitional care unit.
Our partners believe that the effectiveness of their transitional care
unit is "clinically proven" (which might be questionable, but shall be
omitted for now) and demand a randomized-controlled clinical trial to
prove its cost-effectiveness. In this trial transitional care as
delivered for several years at this hospital (intervention group) would
be compared to usual care defined as discharge from hospital and usual
community care at home (control group) for a group of elderly patients.
The randomization procedure would be conducted according to patients
preferences, i. e. if a person is indifferent between both alternatives,
he/she would be randomized to either of the groups. If a person prefers
one intervention, he/she will not be randomized but instead be assigned
to the preferred intervention.
Given that the clinical effectiveness of transitional care as delivered
for several years in this case is regarded as "clinically proven", is a
RCT ethically feasible in this case to prove the cost-effectiveness of
the intervention ?
This would in my opinion result in assigning some patients (i. e. those
assigned to the control group) to a less effective intervention.
Can we consider patients' indifference regarding the treatment options
as sufficient to enter them into the randomization process given the
fact that clinicians (as health professionals) are regarding
transitional care as the more effective intervention ?
In other words: Do you think we should consider other study designs ?
Thank you in advance for comments !
Best regards,
Stefan Hebenstreit
University of Bielefeld
Faculty of Heath Sciences
School of Public Health - WHO Collaborating Center
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