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.