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Titolo:
Methodological issues in analyzing psychological test scores in pediatric clinical trials
Autore:
Lindsey, JC; ODonnell, K; Brouwers, P;
Indirizzi:
Harvard Univ, Sch Publ Hlth, Ctr Biostat AIDS Res, Boston, MA 02115 USA Harvard Univ Boston MA USA 02115 r Biostat AIDS Res, Boston, MA 02115 USA Duke Univ, Med Ctr, Dept Pediat, Durham, NC 27710 USA Duke Univ Durham NCUSA 27710 Med Ctr, Dept Pediat, Durham, NC 27710 USA Baylor Coll Med, Texas Childrens Canc Ctr, Houston, TX 77030 USA Baylor Coll Med Houston TX USA 77030 rens Canc Ctr, Houston, TX 77030 USA
Titolo Testata:
JOURNAL OF DEVELOPMENTAL AND BEHAVIORAL PEDIATRICS
fascicolo: 2, volume: 21, anno: 2000,
pagine: 141 - 151
SICI:
0196-206X(200004)21:2<141:MIIAPT>2.0.ZU;2-1
Fonte:
ISI
Lingua:
ENG
Soggetto:
DETECTION LIMIT; INFECTED CHILDREN; LONGITUDINAL DATA; DROP-OUT; ZIDOVUDINE;
Keywords:
clinical trials; longitudinal data; floor scores;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Social & Behavioral Sciences
Clinical Medicine
Citazioni:
31
Recensione:
Indirizzi per estratti:
Indirizzo: Lindsey, JC Harvard Univ, Sch Publ Hlth, Ctr Biostat AIDS Res, 651 Huntington Ave, Boston, MA 02115 USA Harvard Univ 651 Huntington Ave Boston MA USA02115 02115 USA
Citazione:
J.C. Lindsey et al., "Methodological issues in analyzing psychological test scores in pediatric clinical trials", J DEV BEH P, 21(2), 2000, pp. 141-151

Abstract

Clinical trials to address drug dosing, safety, and efficacy issues in thepediatric population are becoming more common. In some studies, tests of mental ability are administered at regular intervals in drug trials for treatment of children with HIV, certain types of cancer, sickle cell anemia, and diabetes. The test scores are used to examine differences between treatments in efficacy and safety over time. In addition to the well-known problems of analyzing repeated measures with incomplete data profiles, the analyses of these data are complicated by a number of unique features, including that children can be so ill that their raw scores cannot be mapped to a normed scaled score, and that children may be in the studies long enough that they transition between the age-appropriate instruments. These issues are often ignored in data analyses and can potentially cause incorrect conclusions regarding treatment efficacy and safety. This article describes these issues and their possible consequences. A simple approach to determine their impact on the statistical analysis of a particular clinical trial is suggested. The approach is illustrated with data from a Phase ill trial in HIV-infected children.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 25/09/20 alle ore 21:31:50