Assessment of health status in chronic hemodialysis patients.

BACKGROUND: We compared three ways of assessing health status in chronic hemodialysis patients: generic questionnaire compared with population norms, disease-specific questionnaire, and open questions. METHODS: Hemodialysis patients (n=83) treated in Geneva canton, Switzerland, answered the Kidney Disease Quality of Life (KDQOL-SF) questionnaire, which combines 12 disease-specific scales with the generic Short-Form 36 (SF36) health survey, and open questions about the most disturbing and most positive aspects of having end-stage renal disease. SF36 scores were compared with those of the general population, and generic health scales were correlated with dialysis-specific scales. RESULTS: Hemodialysis patients had significantly lower scores than general population controls on 7 of 8 SF36 scales, especially physical functioning (-1.2 standard deviation (SD) units, p<0.001) and general health (-1.2 SD, p<0.001), but their mental health was similar (-0.2 SD, p=0.13). All 12 KDQOL dialysis-specific scores correlated significantly with the SF36 mental summary score, but only 6 correlated significantly with the SF36 physical summary score. Open comments suggested that dialysis itself is the chief problem confronting dialysis patients, but also that the predicament of end-stage renal disease may have a positive impact on the lives of some patients. CONCLUSIONS: While physical problems are the biggest difference between dialysis patients and controls, disease-specific scales and open comments highlighted the importance of psychosocial and treatment-related problems among hemodialysis patients. Generic and disease-specific questionnaires, and open comments provide different information about the health status of dialysis patients.

A three-arm study comparing immediate tacrolimus therapy with antithymocyte globulin induction therapy followed by tacrolimus or cyclosporine A in adult renal transplant recipients.

BACKGROUND: Induction therapy with antithymocyte globulin (ATG) reduces the incidence of acute rejection after transplantation. A study was undertaken to assess the efficacy and safety of ATG induction on tacrolimus-based and cyclosporine A (CsA)-based therapies compared with immediate tacrolimus triple therapy in kidney transplant recipients. METHODS: In a 6-month, open-label, randomized, prospective study conducted in 30 European centers, 555 renal transplant patients were randomly assigned to tacrolimus triple therapy (Tac triple, n=185), ATG induction with tacrolimus (ATG-Tac, n=186), or ATG induction with CsA microemulsion (ATG-CsA, n=184); all were combined with azathioprine and corticosteroids. The primary endpoint was incidence and time to first acute rejection episode confirmed by biopsy. RESULTS: Patient demographics and clinical parameters at baseline were similar. Patient and graft survival rates were similar in all groups. The incidence of clinically apparent acute rejection was significantly higher (P=0.003) for Tac triple (33.0%) compared with ATG-Tac (22.6%) and the incidence for ATG-Tac was significantly lower (P=0.004) than for ATG-CsA (37.0%). The incidences of acute rejection confirmed by biopsy (primary endpoint) were 25.4%, 15.1%, and 21.2% for Tac triple, ATG-Tac, and ATG-CsA, respectively (Tac triple vs. ATG-Tac, P=0.004). The incidences of corticosteroid-resistant acute rejection were 7.0% (Tac triple), 4.8% (ATG-Tac), and 10.9% (ATG-CsA) (ATG-Tac vs. ATG-CsA, P=0.038). In the ATG groups, the incidences of leukopenia, thrombocytopenia, serum sickness, fever, and cytomegalovirus infection were significantly higher (P<0.05). CONCLUSIONS: Acute rejection was significantly lower in the ATG-Tac group compared with the ATG-CsA and Tac triple groups. Significantly more hematologic and infectious adverse events were observed in both ATG induction groups.