Marie-Christine Woronoff-Lemsi

Observational study of potential risk factors of medication administration errors.

Objective: Medication administration errors (MAEs) are the second most frequent type of medication errors, as has been shown in different studies in the literature. The aims of this observational study were to assess the rate and the potential clinical significance of MAEs and to determine the associated risk factors. Design: In two departments, Geriatric Unit (GU) and Cardiovascular-Thoracic Surgery Unit (CTSU) of Besançon University Hospital (France), MAEs were identified using the undisguised observation technique and classified according to the definitions of the American Society of Health-System Pharmacists. Injectable administration, lack of nursess standardized protocol for the preparation and administration of drugs, incomplete or illegible prescription and nurses workload were analysed as potential risk factors of MAEs in multivariate logistic regression analysis.Results: During a period of 20 days, opportunities for error concerning 56 patients and 78 MAEs (58 in CTSU and 26 in GU) were observed. The medication administration error rate was 14.9%. Dose errors were the most frequent (41%) errors, followed by wrong time (26%) and wrong rate errors (19%). No potential fatal errors were observed, 8 (10%) were estimated as potentially life-threatening, 20 (26%) potentially significant and 50 (64%) potentially minor. Nurse workload and incomplete or illegible prescriptions were two independent risk factors of MAEs.Conclusion: According to these data, the quality of the medication administration process needs to be optimized in hospitals in order to minimize the incidence of iatrogenic preventable diseases.

Use of a decision analysis model to assess the medicoeconomic implications of FDG PET imaging in diagnosing a solitary pulmonary nodule.

This study assessed the use of positron emission tomography (PET) in identifying and diagnosing solitary pulmonary nodules (SPNs). For this a decision analysis model was constructed, and three alternatives were compared: wait and watch (WW), PET and anatomical computed tomography (PET), and CT plus PET (CT+PET). Transition probabilities were estimated from published data and consultations with experts. Costs of diagnosis were derived from the French reimbursement scale, and treatment costs from a national hospital database of diagnosis-related groups. The base case was defined as a 65-year-old male smoker with a 2-cm SPN and an associated high risk of malignancy of 43%. Evaluation criteria included incremental cost-effectiveness ratios and the proportion of unnecessary operations avoided in patients without malignant SPN. For the base case WW was the least effective and cheapest strategy. CT+PET was more effective and presented lower incremental cost-effectiveness ratio (€3,022 per life-year gained). It also was superior to PET in cost-effectiveness terms and resulted in 4.3% fewer unnecessary resections of benign SPN than did PET. Risk profile analyses performed on SPN malignancy risk showed that CT + PET remains the most cost-effective strategy in the range of 5.7–87%, and that WW is more cost-effective in the range of 0.3–5.0%. CT+PET is thus cost-effective in detecting malignant SPN in patients with a risk of malignity of at least 5.7% and may avoid inappropriate resections of benign SPN. These findings support the attempts to introduce a larger number of PETs in France for SPN diagnosis.

Cytomegalovirus exposure, immune exhaustion and cancer occurrence in renal transplant recipients

The role of Cytomegalovirus (CMV) in carcinogenesis is controversial. We studied whether CMV may contribute to cancer occurrence in renal transplant recipients. We studied a prospective cohort of 455 consecutive patients who received a kidney transplant between January 1995 and December 2006. All cancers and types of cancers were assessed. Lymphocyte phenotype and cytokines production were analysed according to CMV status in a subset population of this cohort. Mean follow‐up was 84 ± 29 months. One hundred and nineteen cancers (26.2%) occurred during the study follow‐up. There was a higher cumulated incidence of cancers in CMV‐exposed patients (30.4% vs. 20%; P = 0.018). Mean time to cancer occurrence was shorter in CMV‐exposed patients than in CMV‐naïve patients (4.7 ± 2.6 vs. 6.7 ± 2.8; P = 0.001). Cox regression analysis revealed that both pretransplant CMV exposure (HR, 1.83; 95% CI, 1.17–2.88; P = 0.009) and post‐transplant CMV replication (HR, 2.17; 95% CI, 1.02–4.59; P = 0.044) were risk factors for cancer. Among CD8+ T cells, exhausted T cells assessed as CD57+CD28‐ were expanded in CMV‐exposed patients (26 ± 20 vs. 9 ± 8%; P < 0.0001), whereas CD8+CD57+IL2‐ cells were more frequent in CMV‐exposed patients. Our results highly suggest that CMV increases the risk of cancer after transplantation.

From Randomised Clinical Trials to Clinical Practice: A Pragmatic Cost-Effectiveness Analysis of Paclitaxel in First-Line Therapy for Advanced Ovarian Cancer

AbstractIntroduction: Paclitaxel plus cisplatin is considered to be the standard first-line therapy for advanced ovarian cancer. Previous to this study, economic data on this combination resulted from randomised clinical trials (RCTs). Therefore, the objective of this study was to compare the clinical and economic outcomes associated with paclitaxel-cisplatin (PC) and cyclophosphamide-cisplatin (CC) regimens using a pragmatic perspective based on daily clinical practice in a French university hospital. Method: A retrospective cost-effectiveness analysis, from the hospital-payer perspective, was carried out as a before-after case study in fifty-nine consecutive women with verified International Federation of Gynaecology and Obstetrics (FIGO) stage II, III or IV ovarian cancer treated between 1995 and 2000. Median overall survival (OS) was used as the primary endpoint. The quality-adjusted time was assessed by the quality-adjusted time without symptoms or toxicity (Q-TWiST) method. Direct medical costs were collected for each patient. Monetary values for French prices in the year 2000 were used and converted to US dollars using an exchange rate of

Incidence and risk-factors of CHOP/R-CHOP-related cardiotoxicity in patients with aggressive non-Hodgkin's lymphoma

US1 = 7 French francs. Several univariate sensitivity analyses were carried out varying unit costs, medical practices and administration of paclitaxel. Results: The incremental cost of the PC regimen was

Clinical and economic impact of epoetin in adjuvant-chemotherapy for breast cancer.

US10 716 per patient. OS and quality-adjusted time were improved by 10.8 and 9.3 months with the PC regimen. The cost per life-year gained and per added QALY were

Economic impact of simplified de Gramont regimen in first-line therapy in metastatic colorectal cancer.

US11 907 and

Cost Effectiveness of High-Dose Chemotherapy with Autologous Stem Cell Support as Initial Treatment of Aggressive Non-Hodgkin's Lymphoma

US13 827, respectively. The robustness of the results was confirmed in sensitivity analyses. Conclusion: Our study suggests that PC may be a cost-effective regimen for advanced ovarian cancer in a French university hospital setting. We reported higher incremental costs and lower clinical benefits than RCT-based findings, suggesting that RCT-based findings were clearly balanced by our pragmatic approach based on clinical practices. Observational studies can provide complementary and balanced data for decision making.

Hospital Costs of Renal Transplant Management

The CHOP regimen with rituximab (R‐CHOP) remains the standard for chemotherapy in patients with aggressive non‐Hodgkins lymphoma (NHL). The cardiotoxicity of doxorubicin appears to be a key problem in clinical practice. We studied the cardiotoxicity of CHOP/R‐CHOP regimen in a retrospective series. The prognostic factors of congestive heart failure (CHF) were investigated, including the impact of empirical cardioprotection by dexrazoxane.

Antidepressant response and fluvoxamine plasma concentrations: a pilot study.

IntroductionAnaemia is a common toxicity in cancer patients and epoetins (EPOs) are now an established treatment. The economic profile of EPO treatment was assessed in patients with breast cancer treated by adjuvant-chemotherapy.Materials and methodsTwo strategies were compared: without treatment by EPO and with the possible use of treatment by EPO (epoetin alfa) when required. The clinical effectiveness criterion was time adjusted to quality of life and economic data included only direct medical costs.Main resultsOne hundred ninety-two patients were included. In the group with the strategy containing the possible use of EPO, 45.5% of patients effectively received EPO. A significant difference in the haemoglobin level profile over time was observed which provided a significant overall benefit of 0.0052 (p<10−4) quality-adjusted life year (QALY) associated with an extra cost of €1,615 (p<10−4). In the base case analysis, the cost per added QALY was estimated as €310,577 with the strategy containing the possible use of EPO.ConclusionThis robust result seems to be unacceptable, but the only relevant point of discussion might be the level of acceptable incremental cost-effectiveness ratio (ICER) for a patient.