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Volume 53, Issue 1, Pages 39-45 (January 2000)


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Comparing treatment valuations between and within subjects in clinical trials Does it make a difference?

Erwin BirnieabCorresponding Author Information, Wilma M. Monincxb, Hans A. Zondervanb, Patrick M.M. Bossuyta, Gouke J. Bonsela

Received 6 June 1997; accepted 20 April 1999.

Abstract 

Valuations may be sensitive to biases, especially if elicited alongside randomized clinical trials. We investigated the construction of valuations assigned by women who entered a randomized clinical trial and were allocated to in-hospital or domiciliary monitoring. Women assigned valuations (0–10 visual analogue scale) to the strategy they had been allocated to and to the alternative strategy. Valuations were expressed as a between-subject difference (assigned by the women allocated to the respective strategies) and as within-subject differences (assigned by all women). Domiciliary monitoring was valued higher by the women allocated to that strategy (P = 0.10). In-hospital monitoring was valued higher by the women allocated to that strategy (P = 0.02). The average within-subject differences differed by allocated strategy (P < 0.01). The within-subject valuation differences showed large variability between and within groups. An overrepresentation of women favoring domiciliary monitoring and asymmetric treatment experience inflated the average within-subject difference in the domiciliary group but deflated that difference in the in-hospital group. Neither the average between-subject difference nor the average within-subject differences are free of bias. Other study designs probably cannot prevent bias. Comparing within-subject and between-subject differences is instructive.

a Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, Room J2-224, PO Box 22700, 1100 DE, University of Amsterdam, Amsterdam, The Netherlands

b Department of Obstetrics and Gynecology, Academic Medical Center, Room J2-224, PO Box 22700, 1100 DE, University of Amsterdam, Amsterdam, The Netherlands

Corresponding Author InformationCorresponding author

PII: S0895-4356(99)00099-2


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