<>Many thanks to all who replied to my query about multicentre clinical
trials. I summarise the answers below.
<>My original query was this: <>I have been asked whether I know of a
reference giving the views of medical statisticians looking at centre
effects in multi-centred clinical trials. Does anybody have any suggestions?
From Ly-Mee Yu
Here is the one I can think of:
<>Localio AR, et al. Adjustment for center in multicenter studies: an
overview. Ann Intern Med 2001; 135: 112-23
From Anna Passera:
<>My university friend, Matthew Jones has carried out a PhD project on
this subject in collaboration with GSK. And has since published a paper
with other authors. Even though I work at GSK, my knowledge about this
subject is entirely from Matthew Jones.
Here is the reference to the paper:
<>Fedorov V., Jones B., Jones C.M. and Zhigljavsky A.A - Estimation of
the treatment difference in multicenter trials, Journal of
Biopharmaceutical Statistics, Volume 14, Number 4, 1037 - 1063, 2004.
And he has also given me permission to send on his PHd project to you if
you require it.
From Andrea Manca:
<> We have explored this issue in the context of trial-based
cost-effectiveness analysis (there are some useful references at the
back of our manuscript):
<>Manca A,Rice N,Sculpher MJ,Briggs AH,Assessing Generalisability By
Location in Trial-based Cost-effectiveness Analysis: the Use of
Multilevel Models.. Health Economics. 14(5):471-85. May 2005.
<>The above is a methodological paper, but I have implemented the ideas
outlined in as part of the CEA of the UKBEAM trial:
BEAM Trial Investigators,UK Back pain Exercise And Manipulation (UKBEAM)
randomised trial: cost-effectiveness of physical treatments for back
pain in primary care. British Medical Journal. 329(7479):1381-1386. 10
Dec 2004.
<>In terms of analytical work on the clinical effectiveness side, Chris
Roberts has published something specific to "health professional effect"
rather than "centre", I think this was<>
Roberts C. The implication of variation in outcome between health care
professionals for the design and analysis of randomised controlled
trials. Statistics in Medicine 1999;18:2605-2615. <>
Other interesting references include <>
Localio AR, Berlin JA, Ten Have TR, Kimmel SE. Adjustment for center in
multicenter studies: an overview. Annals of Internal Medicine
2001;135:112-123. <>
Skene AM, Wakefield JC. Hierarchical models for multicentre binary
response studies. Statistics in Medicine 1990;9:919-29.
From Doug Altman:
The following may be useful:
A series of papers in J Clin Epidemiol:
Within trial variation--a false trail? Altman DG J Clin Epidemiol. 1998
Apr;51(4):301-3.
Comment in: J Clin Epidemiol. 1998 Apr;51(4):297-9.
<>Comment on:
J Clin Epidemiol. 1997 Jul;50(7):749-51.
J Clin Epidemiol. 1997 Jul;50(7):753-5.
ALSO:
<>Stat Methods Med Res. 2005 Jun;14(3):205-48. The design of multicentre
trials. Fedorov V, Jones B. <>
J Biopharm Stat. 2004 Nov;14(4):1037-63. Estimation of the treatment
difference in multicenter trials. Fedorov V, Jones B, Jones M,
Zhigljavsky A.
<>
J Dent Res. 2004;83 Spec No C:C119-21. Related Articles, Links Methods
for pooling results from multi-center studies. Worthington H. Free at
http://jdr.iadrjournals.org/cgi/reprint/83/suppl_1/C119 <>
Ann Intern Med. 2001 Jul 17;135(2):112-23. Adjustments for center in
multicenter studies: an overview. Localio AR, Berlin JA, Ten Have TR,
Kimmel SE. <>
Thanks to all.
Martin
--
***************************************************
J. Martin Bland
Prof. of Health Statistics
Dept. of Health Sciences
Seebohm Rowntree Building Area 2
University of York
Heslington
York YO10 5DD
Email: [log in to unmask]
Phone: 01904 321334
Fax: 01904 321382
Web site: http://www-users.york.ac.uk/~mb55/
***************************************************
|