Quality of life and clinical outcome in psoriasis patients using intermittent cyclosporin.

BACKGROUND: Psoriasis causes considerable patient morbidity and can seriously affect a patient's quality of life (QoL). OBJECTIVES: To investigate the relationships between changes in QoL and measures of severity and extent of disease, and itch, in patients with chronic plaque psoriasis receiving intermittent short courses of cyclosporin (Neoral). METHODS: This study was performed as part of an international trial investigating the safety, efficacy and total costs of intermittent short courses of cyclosporin (the PISCES study). All patients received cyclosporin until clearance and were then followed up until relapse. On relapsing, patients received another course. Patients were followed up for a minimum of 1 year during which they could receive as many courses of treatment as necessary. In a subgroup (n = 255) of patients in the trial, the Dermatology Life Quality Index (DLQI) was used to assess the impact of psoriasis and its treatment on the patients' health status at the beginning and end of each treatment period. At the beginning and end of each treatment period, as well as at 2-weekly visits, the extent and severity of disease, together calculated into a modified Psoriasis Area and Severity Index (PASI), and itch were recorded. Data were analysed using the Wilcoxon matched pairs test, multivariate Hotelling's T2 tests, and Spearman's rank correlation coefficients (rs). RESULTS: During treatment, a clear impact on the overall DLQI scores and in the scores in all six DLQI headings was found (i.e. an improvement in QoL; P < 0.001 in all scores). Also, significant decreases in PASI and itch scores were found (P < 0.001). Multivariate analyses confirmed that a decrease in PASI and itch scores was accompanied by an impact on the DLQI scores during and between the two treatment periods (P < 0.0001). Statistically significant but weak correlations were found between changes in QoL and changes in PASI (rs = 0.40 and 0.24 for the first and second treatment periods, respectively) and itch scores (rs = 0.31 and 0.42, respectively). CONCLUSIONS: Intermittent short courses of cyclosporin clearly improve the QoL of the patients and decrease the extent and severity of disease and itch. Changes in clinical outcome scores are accompanied by changes in QoL. The weak correlations between changes in QoL and clinical measures may suggest that no clear relationship between QoL and clinical outcomes exists. However, due to the inclusion and exclusion criteria of the study, both QoL and clinical outcome measures do not show much variation among this homogeneous group of patients. As long as the relationship between clinical outcome parameters and measures of QoL is not completely clear, both measures of health should be considered in adequate, patient-orientated clinical decision making.

Economic evaluation of cancer treatments: methodological and practical issues.

Economic evaluation is a comparative analysis of alternatives in terms of both their costs and consequences. Therefore, the basic task of economic evaluation is to identify, measure, value and compare the costs and effects of the alternatives being considered. In this paper, the methodology of economic evaluation in general and in cancer in particular is reviewed and practical issues are illuminated. In the treatment of cancer patients not only survival and disease-free survival are important outcome parameters, but also quality of years alive. Hence, specific attention is given to the measurement and valuation of quality of life. Economic evaluation is intended to support health policy at different levels of decision making. In cancer treatment, health policy concerns both preventive, curative and palliative strategies, and decisions are often made at the micro and macro level. Economic evaluation can provide essential information on the costs and benefits of each option, and consequently on the optimal policy mix, and thus support decisions on the adoption and utilization of new treatments. Such information may assist policy makers in formulating regulatory policies and legislation, industry in developing products, health professionals in treating and serving patients, and consumers in making personal health decisions.

Clonal dysregulation of the antibody response to tetanus-toxoid after bone marrow transplantation.

After bone marrow transplantation (BMT), a prolonged dysregulation of humoral immunity can be observed. In the present study, we investigated whether this is reflected in an abnormal production of specific antibodies (Ab) to the T-cell-dependent recall antigen tetanus-toxoid (TT). The study group consisted of children receiving transplants of an unmodified allogeneic graft and of adults receiving either a T-cell-depleted allogeneic or an unmodified autologous BM graft. Findings were compared with those in healthy controls. In pediatric graft recipients, who were routinely revaccinated early after BMT, the Ab response was quantitatively superior to that in adult graft recipients who did not receive early revaccination. In the majority of graft recipients, the time period after vaccination required to reach the peak level of antibodies was prolonged and the number of responding TT-specific B-cell clones was markedly decreased in comparison with controls. In controls, a low frequency of dominant B-cell clones may produce low quantities of homogeneous Ab components (H-Ab) against a heterogeneous background. However, in BM graft recipients, "overshooting" of Ab production by separate B-cell clones was observed, resulting in the development of H-Ab at a relatively high concentration. These abnormalities were present up to 10 years after BMT, irrespective of either the age of the recipient, the modulation of the graft, or the vaccination schedule used. It is hypothesized that the dysregulated Ab production is the consequence of activation of a restricted number of resting memory B cells, present in germinal centers, repopulating gradually after BMT. Our data show that routine revaccination early after BMT improves the humoral immune response. However, because of a clonally dysregulated Ab production, long-lasting qualitative defects may be present even after normalization of Ab titers.

[Quantification of excessive length of hospital stay ('wrong bed problem'); hip fractures in the elderly]. / Kwantificering van te langdurige ziekenhuisopname ('verkeerde-beddenproblematiek'); heupfracturen bij bejaarden.

OBJECTIVE: To assess the magnitude of hospital bed misoccupation by elderly patients admitted because of a hip fracture. DESIGN: Prospective clinical study. SETTING: Department of surgery-traumatology of Leiden University Hospital, the Netherlands. METHOD: All patients with a hip fracture admitted from January 1991 to April 1993 were registered for age, ability level, pre-existent disease, housing situation, social environment, morbidity, mortality and duration of hospital stay. The misexploitation of hospital beds was calculated based on an optimal hospital stay of 9 days. When complications occurred, necessitating longer medical treatment, this optimum was adjusted in each individual case. RESULTS: The mean hospital stay in 123 patients who had to be transferred to a nursing home when they had previously lived in their own homes or in an old people's home was 23.8 days, and 11.6 days above the optimum; for patients who could return to their previous housing situation these figures were 13.5 and 4.2 respectively (p < or = 0.05). Age, ability level, pre-existent disease and less importantly the social environment influenced the possibilities for a patient to return to his/her own home. Use of a clinimetric scale, which objectively assessed the probability of resocialisation, decreased the mean hospital stay from 28-30 days to less than 17. CONCLUSION: To minimize the duration of unnecessary hospital stay, use of a clinimetric scale on admission to assess the probability of rapid resocialisation can be useful.