Comparing treatment valuations between and within subjects in clinical trials: does it make a difference?
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.
Birnie
E
E
Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, University of Amsterdam, The Netherlands.
Monincx
W M
WM
Zondervan
H A
HA
Bossuyt
P M
PM
Bonsel
G J
GJ
D000328:Adult; D015982:Bias; D005260:Female; D005323:Fetal Monitoring / Q000379:methods; D006801:Humans; D017063:Outcome Assessment, Health Care; D011247:Pregnancy; D018566:Pregnancy, High-Risk; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D011795:Surveys and Questionnaires