Alberto Ferrando

Predictors of treatment failures during chemotherapy: A prospective study on 110 older cancer patients.

Several instruments have been proposed to improve treatment decisions in elderly cancer patients, but evidence of their impact in clinical practice is limited. The aim of this study was to analyze the role of clinical and functional factors in predicting serious adverse events, including death, severe toxicity or treatment interruption, during chemotherapy in elderly cancer patients. The survey evaluated elderly with lung or colon or breast cancer treated with chemotherapy, followed by S. Giovanni Battista Hospital. We enrolled 110 consecutive patients older than 70 years of age with lung (n=45), colon (n=50) and breast (n=15) cancer between October 2004 and October 2005. Overall, 73/110 patients (66.4%) experienced adverse events as death (n=14), grades III and IV toxicity (n=40), or treatment interruption for other reasons (n=19). The variables with stronger predictivity were advanced stage, toxicity of treatment, level of comorbidity and Karnofsky performance status (KPS). instrumental activities of daily living (IADL) index and age itself were not independent predictors. In conclusion our results confirm the need of a careful selection of elderly patients suitable for chemotherapy, giving more weight to comorbidity and KPS scores than to age itself. The potential role of other functional evaluations need to be further assessed in randomized controlled trials.

An economic evaluation of water birth: the cost‐effectiveness of mother well‐being

PURPOSE To assess the cost-effectiveness of water compared with normal land delivery. METHODS A retrospective controlled study was conducted over a two-year period in a Northern Italian hospital. The cohort included all the 110 women who completed a water birth and 110 women who had a land birth during the same period. The two groups were compared with respect to labour duration, perineal tear and newborns health status. The economic evaluation adopted a cost-effectiveness approach in relation to presence/absence of perineal tears. RESULTS In the water delivery group 58 women (52.7%) experienced at least one perineal tear versus 80 (72.7%) in the traditional delivery group. The mean duration of labour was similar in the two groups. Neonatal well-being, expressed as Apgar score, did not differ significantly among the two groups at the first minute (9.48 vs. 9.28) and was slightly higher at 5 minutes in the water delivery group (9.95 vs. 9.84; P = 0.0269). Water delivery was found to be both more costly [ΔC = €279; 95% confidence interval (CI): 262-296] and more effective in terms of avoided perineal tears. The incremental health care cost per avoided perineal tear because of water delivery was estimated of €1395.7 (95% CI: 1049.2-3608.5). CONCLUSION Water birth, as compared with traditional delivery, allows for an increase in maternal well-being and is cost-effective.

A decision-tree model to estimate the impact on cost-effectiveness of a venous thromboembolism prophylaxis guideline

Background and objective: The impact of clinical guidelines (GL) on venous thromboembolism (VTE) prophylaxis was evaluated in a large Italian hospital with a before/after study. GL were effective in increasing the appropriateness of prophylaxis and in reducing VTE. Following this study, the aim was to estimate the impact of the adopted GL on costs and benefits through a cost-effectiveness analysis. Methods: A decision-tree model was used to compare prophylaxis costs and effects before and after GL implementation. All patients were classified into four risk profiles (low, moderate, high, very high). Outcomes considered were: no event, asymptomatic VTE, symptomatic VTE, fatal pulmonary embolism and major bleeding. Patient risks and the probability of receiving prophylaxis were defined using data from the previous study. Outcome probabilities were derived from the literature. Regional Drg reimbursements and hospital figures were used for costing the events. Results: Despite a marked increase in the number of patients receiving some form of prophylaxis, it was estimated that the introduction of GL reduced the average cost per patient related to VTE from €210 to €181 (−14%), with a parallel absolute decrease in VTE complications (−5%). Results are particularly relevant in the very-high-risk group. Sensitivity analysis confirmed the overall cost savings and gains in effectiveness. Conclusions: The implementation of locally adapted GL on VTE prophylaxis may lead to a benefit in terms of both costs and effects, especially for the highest-risk patients.

Studying factors related to pressure ulcers prevention: a marginal scale model for modelling heterogeneity among hospitals

RATIONALE, AIMS AND OBJECTIVES The purpose of this study was to analyse risk factors associated with the presence of pressure ulcer development in patients referred to several Italian hospitals, taking properly into account the within-hospital outcome correlation. METHODS We analysed data from a prevalence survey coordinated by the European Pressure Ulcer Advisory Panel on 12,000 hospitalized patients in Italy, collecting information on patients risk, presence of ulcers and prevention measures. The article describes the bases which generalized estimating equations rely on as well as their statistical properties. The article compares different model specifications in the light of background knowledge of the survey data and model assumptions, and discusses the potential for this modelling approach to apply in similar statistical situations. RESULTS In accordance with existing literature, factors associated with pressure ulcers in hospitalized patients were identified as Braden scale, age and assistance-connected aspects. Between-hospital variability seemed to be explained by the adopted degree of prevention (use of preventive equipment combined with a repositioning strategy). CONCLUSIONS Modelling the covariance matrix or the scale argument of the correlated binary responses (presence/absence of pressure ulcers) by using moment estimators based on generalized estimating equations prevents optimistic inference and provides an important insight into the role of structural differences among hospitals.

Modeling healthcare costs in simultaneous presence of asymmetry, heteroscedasticity and correlation

Highly skewed outcome distributions observed across clusters are common in medical research. The aim of this paper is to understand how regression models widely used for accommodating asymmetry fit clustered data under heteroscedasticity. In a simulation study, we provide evidence on the performance of the Gamma Generalized Linear Mixed Model (GLMM) and log-Linear Mixed-Effect (LME) model under a variety of data-generating mechanisms. Two case studies from health expenditures literature, the cost of strategies after myocardial infarction randomized clinical trial on the cost of strategies after myocardial infarction and the European Pressure Ulcer Advisory Panel hospital prevalence survey of pressure ulcers, are analyzed and discussed. According to simulation results, the log-LME model for a Gamma response can lead to estimations that are biased by as much as 10% of the true value, depending on the error variance. In the Gamma GLMM, the bias never exceeds 1%, regardless of the extent of heteroscedasticity, and the confidence intervals perform as nominally stated under most conditions. The Gamma GLMM with a log link seems to be more robust to both Gamma and log-normal generating mechanisms than the log-LME model.

Impact of advanced exercise ECG analysis on cost of coronary artery disease management.

BACKGROUND Conventional analysis of exercise electrocardiogram (EX-ECG) has limited accuracy. This study aims to evaluate the potential impact of improving EX-ECG accuracy on costs of diagnosis and number of misdiagnoses of coronary artery disease (CAD). METHODS A decision-tree model was simulated including sequential application of diagnostic procedures for suspected CAD. The model was structured in two main branches (presence or absence of CAD). A probabilistic sensitivity analysis was then performed for several combinations of improvement in test sensitivity and specificity. RESULTS A clear trend in cost reduction was observed at improving EX-ECG specificity (about 8-8.5 million dollars, corresponding to a 5.6-7.6% reduction according to the prevalence level). Wrong diagnoses counted for 9-13% of test. Improvements in test parameters lead to reductions in wrong diagnoses, especially when increasing specificity (8.8-12.5%). CONCLUSIONS A proper improvement in EX-ECG sensitivity and specificity would have a relevant impact on the costs of CAD management, while reducing the number of misdiagnoses.