PubMed · 2895244
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B T Marsh. 1988-03-26. Trials that fail.. https://doi.org/10.1016/s0140-6736(88)91513-9
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Practice in the analysis of clinical trials with continuously measured endpoints is to focus on the difference or percentage change in mean or median response. However, treatments may have effects on the distribution of responses other than on the average response. We sought an approach to such generalized treatment effects that: (i) targets a parameter that is easily understood by our clinical colleagues; and (ii) employs confidence intervals as the basis for inference. We consider one such approach based on work in reliability theory, namely setting Pr[Y>X] as the target parameter, and compare this approach to an earlier one due to O'Brien. The two approaches have similar properties when they both seek to reject the null hypothesis of no effect due to different variances but differ when the larger variance corresponds to the larger mean. In that case, our approach views that the larger variance attenuates the effect of the larger mean. Out suggested approach applies easily to positive control (clinical) equivalence trials.
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We review drug abuse treatment as a means of preventing infection with HIV. Thirty-three studies, with an aggregate of over seventeen thousand subjects, were published in peer-reviewed journals from 1988-1998. Research on the utility of drug abuse treatment as an HIV prevention strategy has focused primarily on methadone maintenance treatment (MMT) rather than other modalities such as residential or outpatient drug-free treatment. Recent research provides clear evidence that MMT reduces HIV risk behaviors, particularly needle-use, and strong evidence that MMT prevents HIV infection. There is less definitive evidence that MMT reduces needle-sharing and unsafe sexual behavior, or that other treatment modalities prevent HIV infection. Future research should take into account patient self-selection processes and investigate other treatment modalities for heroin and stimulant abuse to determine their effects on HIV risk behaviors and HIV infection.