An evaluation of statistical methods for analyzing follow-up gaussian laboratory data with a lower quantification limit

Journal of Biopharmaceutical Statistics

Volumn 25, Issue 4, 2015, Pages 812-829

  Karon, John M ^a   Wiegand, Ryan E ^b   Van De Wijgert, Janneke H ^c   Kilmarx, Peter H ^b  

^a Apex Systems Inc   (United States)

^b CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^c UNIVERSITY OF LIVERPOOL   (United Kingdom)

Author keywords

Laboratory data; Mixed models; Mixture models; Quantification limit

Indexed keywords

MICROBICIDE;

ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; FEMALE; FOLLOW UP; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LIMIT OF QUANTITATION; LOGISTIC REGRESSION ANALYSIS; MAJOR CLINICAL STUDY; MAXIMUM LIKELIHOOD METHOD; MIXED MODEL; MIXTURE MODEL; NONPARAMETRIC TEST; NORMAL DISTRIBUTION; PARALLEL DESIGN; PRIORITY JOURNAL; SAMPLE SIZE; SIMULATION; STATISTICAL ANALYSIS; STATISTICAL MODEL; STUDY DESIGN; VARIANCE; EVALUATION STUDY; HIV INFECTIONS;

CROSS-OVER STUDIES; DATA INTERPRETATION, STATISTICAL; FEMALE; FOLLOW-UP STUDIES; HIV INFECTIONS; HUMANS; NORMAL DISTRIBUTION;

EID: 84930802555     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2014.920858     Document Type: Article

References (23)

1. Baeten, J. M., Kahle, E., Lingappa, J. R., Coombs, R. W., Delany-Moretlwe, S., Nakku-Joloba, E., Mugo, N. R., Wald, A., Corey, L., Donnell, D., Campbell, M. S., Mullins, J. I., Celum, C., the Partners in Prevention HSV/HIV Transmission Study Team. (2011). Genital HIV-1 RNA predicts risk of heterosexual HIV-1 transmission. Science Translational Medicine 3:77ra29.
2. Chu, H., Nie, L., Cole, S. R. (2006). Sample size and statistical power assessing the effect of interventions in the context of mixture distributions with detection limits. Statistics in Medicine 25:2647-2657.
3. Dunne, E. F., Whitehead, S., Sternberg, M., Thep-Amnuay, S., Leelawiwat, W., McNicholl, J. M., Sumanapun, S., Tappero, J. W., Siriprapasiri, T., Markowitz, L. (2008). Suppressive acyclovir therapy reduces HIV cervericovaginal shedding in HIV-1 and HSV-2-infected women, Chiang Rai, Thailand. JAIDS 49:77-83.
4. Farewell, V. T. (1983). The use of mixture models for the analysis of survival data with long-term survivors. Biometrics 3:1041-1046
5. Fedorov, V., Mannino, F., Zhang, R. (2009). Consequences of dichotomization. Pharmaceutical Statistics 8:50-61.
6. Gehan, E. A. (1965). A generalizedWilcoxon test for comparing arbitrarily singly-censored samples. Biometrika 52:205-223.
7. Hughes, J. P. (1999). Mixed effects models with censored data with application to HIV RNA levels. Biometrics 55:625-639.
8. Journot, V., Chene, G., Joy, P., Saves, M., Jacqmin-Gadda, H., Molina, J.-M., Salamon, R., the ALBI Study Group. (2001). Viral load as a primary outcome in human immunodeficiency virus trials: A review of statistical analysis methods. Controlled Clinical Trials 22:639-658.
9. Lachenbruch, P. A. (2001) Comparisons of two-part models with competitors. Statistics in Medicine 20:1215-1234.
10. Lubin, J. H., Colt, J. S., Camann, D., Davis, S., Cerham, J. R., Seerson, R. K., Bernstein, L., Hartge, P. (2004). Epidemiologic evaluation of measurement data in the presence of detection limits. Environmental Health Perspectives 112:1691-1696.
11. Lyles, R. H., Lyles, C. M., Taylor, D. J. (2000). Random regression models for human immunodeficiency virus ribonucleic acid data subject to left censoring and informative drop-outs. Applied Statistics 49:485-497.
12. Lynn, H. S. (2001). Maximum likelihood inference for left-censored HIV RNA data. Statistics in Medicine 20:33-45.
13. McLean, C., van de Wijgert, J. H. H. M., Jones, H. E., Karon, J. M., McNicoll, J. M., Whitehead, S. J., Braunstein, S., Achalapong, J., Chaikummao, S., Tappero, J. W., Markowitz, L. E., Kilmarx, P. H. (2010). HIV genital shedding and safety of Carraguard use by HIV-infected women: A crossover trial in Thailand. AIDS 24:717-722.
14. Molina, J.-M., Andrade-Villaneuva, J., Chevarria, J., Chetotisakd, P., Corral, J., David, N., Moyle, G., Mancini, M., Percial, L., Yang, R., Thiry, A., McGrath, D., for the CASTLE Study Team. (2008). One-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naïve HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. The Lancet 372:646-655.
15. Moulton, L. H., Curriero, F. C., Barroso, P. F. (2002). Mixture models for quantitative HIV RNA data. Statistical Methods in Medical Research 11:317-325.
16. Nie, L., Chu, H., Cheng, Y., Spurney, C., Nagaraju, K., Chen, J. (2009). Marginal and conditional approaches to multivariate variables subject to limit of detection. Journal of Biopharmaceutical Statistics 19:1151-1161.
17. Randles, R. H., Wolfe, D. A. (1979). Introduction to the Theory of Nonparametric Statistics. New York, NY: John Wiley & Sons.
18. Schouten, H., Kester, A. (2010). A simple analysis of a simple crossover trial with a dichotomous outcome measure. Statistics in Medicine 29:193-198.
19. Senn, S. (2002). Cross-over Trials in Clinical Research, 2nd ed. Chichester, England: John Wiley & Sons. Senn, S. (2003). Disappointing dichotomies. Pharmaceutical Statistics 2:239-240.
20. Senn, S., Holford, N., Hockey, H. (2012). The ghosts of departed quantities: Approaches to dealing with observations below the limit of quantitation. Statistics in Medicine 31:4380-4295. doi:10. 1002/sim5515.
21. Thiebaut, R., Jacqmin-Gadda, H. (2004). Mixed models for longitudinal left-censored repeated measures. Computer Methods and Programs in Biomedicine 74:255-260.
22. Thiebaut, R., Jacqmin-Gadda, H. (2007). Corrigendom to "Mixed models for longitudinal leftcensored repeated measures". Computer Methods and Programs in Biomedicine 87:78-79.
23. Wiegand, R. E., Rose, C. E., Karon, J. M. (2014). Comparison of methods for analyzing twogroup, cross-sectional data with an outcome subject to a detection limit. Statistical Methods in Medical Research. doi:10. 1177/0962280214531684.