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Background. Although the patient experiences the symptoms, only symptoms that providers recognize and report "count" in most clinical and research settings. Reliance upon provider-report has been justified by the claim that providers report only "clinically important" symptoms.

Objective. To determine whether provider-reported symptoms constitute a more "clinically important" subset of patient-reported symptoms in HIV infection.

Design. Secondary analyses of AIDS Clinical Trials 175 (ACTG 175), a randomized controlled trial of combination antiviral therapy among patients with moderate HIV disease.

Setting. Large, multicenter study.

Patients. 1,262 patients who participated in the health-related quality of life (HRQOL) sub-study and for whom providers completed symptom forms.

Measurements. Patient- and provider-reported symptoms, HRQOL, risk of recent hospitalization, survival, CD4 cell count, and plasma HIV-1 RNA levels.

Results. On average, providers reported 3-fold fewer symptoms than patients did, but the degree of under report varied by symptom. When patient-reports were used as a gold standard, provider-reports demonstrated poor sensitivity (mean 0.25) and good specificity (mean 0.96). Agreement beyond chance was fair (mean [kappa] 0.35) and did not improve when weighted by symptom severity. Site specific variation was greater for provider than for patient-reported symptoms (R2: 0.15 and 0.05 respectively). Patient-reported symptoms were substantially more strongly associated with the physical health scale and all HRQOL subscales than provider-reported symptoms (P <0.0001). Patient-reported symptoms were equally strongly associated with survival (P >0.50) and recent hospitalization as provider-reported symptoms (P >0.48). Of note, patient-reported symptoms were independently associated with survival and recent hospitalization after adjustment for CD4 cell count and plasma HIV-1 RNA levels (P <0.05).

Conclusions. Provider-reported symptoms are not a more clinically important subset of patient-reported symptoms. Patient-reported symptom checklists are likely to be more complete and more strongly associated with HRQOL. Further, patient-reported symptoms are as related to recent hospitalization and survival as provider-reported symptoms. An HIV specific, patient-completed symptom checklist might substantially improve symptom reporting for adverse drug event monitoring, clinical management and medical research.

(C) 2001 Lippincott Williams & Wilkins, Inc.