Hi Eric, Leigh-Ann, all,
I'm not sure I agree.
While unpublished data are used in some reviews, and what Ahmed suggests
would certainly help reduce bias in the interpretation of these results, you
would also need to be able to demonstrate that there was no bias in your
search strategy, and I think that it would be very hard to do so in this
case. There are two issues - the company involved may be much more likely
to send things your way that portray them in a positive light - for
understandable reasons, but ones which may conflict with your own goals of
conducting an impartial systematic review. Second, would you have been
equally likely to get hold of comparable info about products made by other
companies? Your search strategy should demonstrate as far as possible that
(a) you would have been just as likely to get this sort of information about
the client's product, as about other companies' medical devices, and (b)
that the information you would 'find' through the search strategy would be
unbiased in terms of how it portrays the device - other things being equal,
you'd be just as likely to come across info on the negative features of the
device.
Any ideas for how to get around this?
Best wishes,
Catherine
_____
From: Evidence based health (EBH)
[mailto:[log in to unmask]] On Behalf Of Ahmed M.
Abou-Setta, MD
Sent: 21 July 2010 18:22
To: [log in to unmask]
Subject: Re: question re using unpublished, industry supplied data in
systematic reviews
Hi Eric and Leigh-Ann,
What you are describing is the grey literature; that semi-black, semi-white
area that comprises of material not readily available from the published
literature. There are many forms of grey literature and unpublished data
from the files of the manufacturer. It is both important and vital to
include this information because this information may not be available from
any other source outside the company files (unless it was published). This
will diminish the probability of publication bias and add merit to your
systematic review. Cochrane systematic reviews, health technology
assessments, comparative effectiveness reviews, etc. all use unpublished
data, including from industry. The important this is that you transparent
where you got the information and to keep yourself sheltered from any
potential risk of bias towards or against the companies involved. Example,
when performing comparative effectiveness reviews for AHRQ, we are not
allowed to have any contact with the drug or devise manufacturers. This is
done for us by a third independent party to shield us from any possible
notion of bias. But in the end, the companies involved are asked to provide
what is known as a Scientific Information Packet (SIP) containing anything
from monographs to unpublished, or in-press articles, they would like us to
consider.
Hope this helps.
Best wishes,
Ahmed
_______________________________________
Ahmed M. Abou-Setta, MD, PhD
Postdoctoral Fellow/ Project Coordinator,
University of Alberta Evidence-Based Practice Center (UA-EPC)
Alberta Research Centre for Health Evidence (ARCHE)
University of Alberta (Canada)
Principal Evidence-based Medicine Consultant, PharmArchitecture Limited (UK)
Member, Editorial Advisory Board, The Open Medical Devices Journal
Member, Geneva Foundation for Medical Education & Research
Member, Menstrual Disorders & Subfertility Subgroup, Cochrane Collaboration
Aberhart Centre One, Room 8412
11402 University Avenue
Edmonton, Alberta
CANADA T6G 2J3
Tel: (780) 492-6248
Fax: (780) 407-6435
E-mail: [log in to unmask]
[log in to unmask]
Website: http://www.ualberta.ca/ARCHE/
From: Evidence based health (EBH)
[mailto:[log in to unmask]] On Behalf Of Topfer, Leigh-Ann
Sent: July 21, 2010 11:04 AM
To: [log in to unmask]
Subject: question re using unpublished, industry supplied data in systematic
reviews
Hi,
Question posted below on behalf of a colleague who would appreciate your
advice on this.
Thanks for your help. Cheers,
Leigh-Ann
From: Eric Schuur [mailto:[log in to unmask]]
Sent: Wednesday, July 21, 2010 9:29 AM
To: [log in to unmask]
Subject: [AMWA.EDITING-WRITING] Systematic Literature Review Content
I am working on a systematic literature review covering clinical studies of
a class of medical devices. The client in this case manufactures one of
these devices and wants to use this review as part of a regulatory filing.
The client is asking if we think it would be appropriate to add some
information about safety features of the device to the clinical literature
review report.
Note that this information is being given to us by the client and is not in
the literature. My guess is that the client wants to emphasize the safety
of their device since it is not yet on the market.
I have my opinion about this, but don't have data to support it. Does any
one of you have a feeling about whether including this sponsor-provided info
is appropriate in a systematic literature review?
Many thanks for your feedback!
Eric
Eric R. Schuur, Ph.D.
Medical and Scientific Communications
VMWA LLC
www.VMWA.Biz <http://www.VMWA.Biz>
(650) 224-4178
Leigh-Ann Topfer
Coordinator, Information Services
Health Technology & Policy Unit
School of Public Health
University of Alberta
3021 Research Transition Facility
8308-114 St
Edmonton, AB Canada T6G 2V2
phone: (780) 492-9079
fax: (780) 248-1546
e-mail: [log in to unmask]
