Application of random effects models and other methods to the analysis of multidimensional quality of life data in an AIDS clinical trial.
BACKGROUND
Current analytic methods applied to multidimensional health-related quality of life (HRQOL) data do not borrow strength across analyses and do not produce summary estimates of effect.


OBJECTIVE
To compare a random effects modelling approach for the analysis of multidimensional HRQOL data to the following: (1) separate analyses for each dimension; (2) O'Brien's global test procedure; and (3) multivariate analysis of variance (MANOVA).


METHODS
Randomized clinical trial comparing 3 treatments (Trimethoprim-Sulfamethoxazole [TS], Dapsone-Trimethoprim [DT], and Clindamycin-Primaquine [CP] for Pneumocystis carinii pneumonia [PCP]).


METHODS
Patients with PCP enrolled in AIDS Clinical Trials Group Protocol 108.


METHODS
A 33-item battery assessing 7 dimensions of HRQOL: physical functioning, pain, energy, general health perceptions, disability, pulmonary symptoms, and constitutional symptoms.


RESULTS
Analyses focused on changes in score from baseline to Day 7 (n = 145). Separate analyses for each dimension suggested a trend favoring CP versus TS, but using a Bonferroni correction no differences were statistically significant. O'Brien's global procedure for a test of no-treatment effect versus superiority of one treatment yielded P = 0.07. MANOVA did not reveal significant differences among treatment groups. A random effects model using fixed treatment and dimension effects and separate random effects for each person showed a significant overall treatment effect (P = 0.02); changes in scores for CP averaged 10 points greater than for TS.


CONCLUSIONS
Random-effects models provide a flexible class of models for analyzing multidimensional quality of life data and estimating treatment effects because they borrow strength across dimensions.
Wu
A W
AW
Department of Health Policy and Management, Johns Hopkins University, Baltimore, MD, USA. awu@jhsph.edu
Gray
S M
SM
Brookmeyer
R
R
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000523:psychology*; D000203:Activities of Daily Living; D003627:Data Interpretation, Statistical; D015987:Effect Modifier, Epidemiologic; D006304:Health Status; D006801:Humans; D015337:Multicenter Studies as Topic; D015999:Multivariate Analysis; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012044:Regression Analysis; D015203:Reproducibility of Results; D012107:Research Design; D018709:Statistics, Nonparametric