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  • 1
    ISSN: 1573-2649
    Keywords: Quality of life ; missing data ; MAC bactaeremia ; non-random drop-out.
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Quality of life was measured in a study of two multidrug regimens for mycobacterium avium complex MAC bactaeremia using the MOS-HIV questionnaire. The effect of treatment on quality of life was estimated at each follow-up time in three ways: (1) using only the observed data, (2) after assigning the worst possible quality of life scores for individuals who died, and (3) after imputing missing scores for patients who either died or dropped out of the study. The overall quality of life scores were also compared between treatment groups with categorical generalized estimating equation models and three-dimensional graphs. Of the 179 patients included in these analyses, 84 (47%) either died or dropped out during the 16 week study period. When the quality of life scores were compared between the treatment groups with the Wilcoxon rank sum test using only the observed data, there was no significant difference between the groups at 16 weeks of follow-up. When the worst possible quality of life scores were assumed for patients who had died, both the magnitude and the statistical significance of the difference in the quality of life scores between the groups increased. Imputing missing data for patients who either dropped out or died resulted in even larger differences in quality of life between the treatment groups. We conclude that ignoring missing data due to drop-outs and death can result in an underestimation of the treatment effect and overly optimistic statements about the outcome of the participants on both treatment arms due to the selective drop-out of participants with poorer quality of life. To obtain a valid assessment of the effect of treatment on quality of life, the experience of the patients who died or dropped out of the study must be considered.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1435-4373
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract A randomized trial was conducted to compare the efficacy and safety of fluconazole versus that of amphotericin B in the treatment of candidemia in non-neutropenic adults. Enrollment was stratified by disease severity (APACHE II score). Patients were randomized (1∶:1) to receive amphotericin B 0.6 mg/kg/day (cumulative dose 8 mg/kg) or fluconazole 800 mg intravenous loading dose, then 400 mg daily for four weeks (intravenous for at least 10 days). Patients were monitored for six months. A total of 106 patients were enrolled. A protocol amendment implemented midway through the trial required patients to be removed from the study and treated with amphotericin B if species identification indicated candidemia due toCandida glabrata orCandida krusei. Baseline characteristics were similar for the two groups; 103 patients (fluconazole, 50; amphotericin B, 53) met the major enrollment criteria. The intention-to-treat analysis indicated successful therapy in 50% of fluconazole recipients compared to 58% of the amphotericin B group (p=0.39; one-sided 95% Cl, −8 to 24%). The efficacy analysis included 84 patients (fluconazole, 42; amphotericin B, 42); successful outcomes were observed in 57% and 62% of cases in the fluconazole and amphotericin B groups, respectively (p=0.66: one-sided 95% Cl, −12 to 22%). The mortality at day 14 for the fluconazole group was 26% and for the amphotericin B group 21% (p=0.52; chi-square test) and remained similar throughout the course of follow-up. Drug-related adverse events were more frequent with amphotericin B than with fluconazole and prompted switching of therapy for two (4%) and zero cases, respectively. Fluconazole and amphotericin B were associated with similar clinical response rates and survival in the treatment of candidemia among non-neutropenic patients; however, drug-related adverse events were more frequent with amphotericin B.
    Type of Medium: Electronic Resource
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