7th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 13–16 November 2005, Dublin, Ireland

DISAGREEMENT BETWEEN CLINICIANS' AND PATIENTS' REPORTED OUTCOMES IN LIPODYSTROPHY

M Duracinsky^1,3, A Wu² and O Chassany^3
1 Hopital de Bicetre, Le Kremlin-Bicetre, France; ² Johns Hopkins University, Baltimore, MD, USA; ³ Département de la Recherche Clinique et du Développement, Assistance Publique – Hopitaux de Paris, Paris, France

Antiviral Therapy 2005; Supplement 3:L25 (abstract no. 38)

OBJECTIVES: Lipodystrophy may greatly impair quality of life (QoL). Nevertheless, the recognition of the scientific value of QoL and more broadly the patient’s perspective in evaluating therapies is questioned. It may be useful to quantify the added value of the patient’s perspective, using correlations between patient-reported outcomes (PROs) and clinician-reported and biological outcomes.

METHODS: We performed a cross-sectional survey in 143 French HIV outpatients with lipodystrophy. Clinical and demographic data were collected. Patients completed a new specific lipodystrophy questionnaire, “Assessment of Body Change and Distress” (ABCD), consisting of three parts: signs of lipodystrophy (6 items), global satisfaction (n=1) and 20 items evaluating QoL. A HIV specific (MOS-HIV) and generic (SF-12) QoL questionnaires were also filled-in.

RESULTS: Mean age was 43 ±10 years (71% of men), and mean duration of HAART was 4.5 ±1.7 years. ABCD QoL score is weakly or not associated with viral load (r=0.03), CD4 count (r=0.13) and CDC classification (P=NS). Its correlation with the clinician’s report of number of sites of lipodystrophy is weak (r=0.17). Correlations between different PROs are logically higher. ABCD QoL score is more correlated with the patient’s report of number of sites of lipodystrophy (r=0.39) and with satisfaction (r=0.58). ABCD QoL score is correlated with health distress and social dimensions of the MOS-HIV (r>0.6) and with mental component of the SF-12 (r=0.65), but not with physical dimensions of these questionnaires (r<0.2).

CONCLUSIONS: PROs are weakly correlated with biological markers, and although overlapping, each of the PROs measures a distinct concept. Clinicians cannot infer the QoL of their patients neither from a viral load nor from a clinical exam. The patient’s perspective is essential in medical decision making and so it is with lipodystrophy: that is the psychological and social distress related to the body changes must be measured in clinical trials, to make sure that life is not lengthened at the expense of its quality.

Download PDF of this abstract.

2005-11-13
38

Copyright © 2005 - International Medical Press Ltd. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Medical Editor, International Medical Press, 36 St Mary-at-Hill, London EC3R 8DU, United Kingdom.