Wu AW, Gray S, Brookmeyer R, Safrin S; International Conference on AIDS.
Int Conf AIDS. 1996 Jul 7-12; 11: 229 (abstract no. Tu.B.112).
Johns Hopkins University, Baltimore, Maryland, USA. Fax: 410-955-0470. E-mail: awu@phnet.sph.jhu.edu.
Objective: To determine quality of life (QOL) outcomes in a randomized, double-blind, multicenter trial of oral trimethoprimsulfamethoxazole (TS), dapsone-trimethoprim (DT), and clindamycin-primaquine (CP) for treatment of mild-to-moderate Pneumocystis carinii pneumonia (PCP) in patients with AIDS. Methods: Subjects were enrolled from May 1991-June 1993. Eligible patients had HIV infection, confirmed PCP and an alveolararterial gradient of less than or equal to 45 mmHg. Study therapy was administered for 21 days plus or minus 24 hours. QOL outcomes were assessed using a self-administered battery of scales. Physical functioning was assessed using the Duke Activity Status Index (DASI), a 12-item index weighted on the basis of known metabolic costs of each activity. Energy, pain, and general health perceptions were measured using scales from the MOS-HIV. Disability was measured using bed days and days of reduced activity. Symptom severity was assessed for pulmonary (cough, dyspnea, chest tightness) and other symptoms (fever, pain, nausea, rash, dizziness). The questionnaire was available in English and Spanish, and took about 5 minutes to complete. Changes in health status scores were analyzed using Kruskal-Wallis and Wilcoxon rank-sum tests at day 7 and day 21. To provide a summary statistic, a random effects model was used with initial group assignment and dimension of QOL as fixed effects, and person as a random effect. Results: For 181 eligible subjects, completion rates at baseline, day 7 and day 21 were 87%, 80% and 74%, respectively. Completion rates were balanced across groups at baseline and day 7, and were highest for the CP group at day 21. Respondents and non-respondents were similar at all time points. Survival, treatment failure, and incidence of adverse events were similar in the three groups, but patterns of toxicity differed. QOL scores improved over time for all groups. For example, by day 7 when comparing TS, DT and CP groups, general health perception scores improved 5.6, 11.8, and 15.9 points, respectively. Multivariable analyses showed that averaged across all dimensions patients on CP reported changes in scores about 10 points higher than patients on TS (p=0.007). By day 21 patients had improved further but differences between groups were less evident, with only a trend favoring DT over TS (8 points, p=.07). Conclusion: Using conventional outcomes, the 3 treatments were similar. Data on QOL suggested that patients on CP recovered slightly faster than patients on TS, but that the treatments had similar efficacy over 3 weeks. In this study, inclusion of data on patient reported health status complemented the results obtained using other outcome variables.
Publication Types:
Keywords:
- Acquired Immunodeficiency Syndrome
- Blindness
- Clindamycin
- Clinical Protocols
- Dapsone
- Double-Blind Method
- HIV Infections
- Health Status
- Humans
- Life
- Multicenter Study
- Pneumonia, Pneumocystis
- Primaquine
- Quality of Life
- Statistics, Nonparametric
- Treatment Failure
- Treatment Outcome
Other ID:
UI: 102217936
From Meeting Abstracts