Eva Pagano

Early vs late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients: a randomized controlled trial.

CONTEXT Tracheotomy is used to replace endotracheal intubation in patients requiring prolonged ventilation; however, there is considerable variability in the time considered optimal for performing tracheotomy. This is of clinical importance because timing is a key criterion for performing a tracheotomy and patients who receive one require a large amount of health care resources. OBJECTIVE To determine the effectiveness of early tracheotomy (after 6-8 days of laryngeal intubation) compared with late tracheotomy (after 13-15 days of laryngeal intubation) in reducing the incidence of pneumonia and increasing the number of ventilator-free and intensive care unit (ICU)-free days. DESIGN, SETTING, AND PATIENTS Randomized controlled trial performed in 12 Italian ICUs from June 2004 to June 2008 of 600 adult patients enrolled without lung infection, who had been ventilated for 24 hours, had a Simplified Acute Physiology Score II between 35 and 65, and had a sequential organ failure assessment score of 5 or greater. INTERVENTION Patients who had worsening of respiratory conditions, unchanged or worse sequential organ failure assessment score, and no pneumonia 48 hours after inclusion were randomized to early tracheotomy (n = 209; 145 received tracheotomy) or late tracheotomy (n = 210; 119 received tracheotomy). MAIN OUTCOME MEASURES The primary endpoint was incidence of ventilator-associated pneumonia; secondary endpoints during the 28 days immediately following randomization were number of ventilator-free days, number of ICU-free days, and number of patients in each group who were still alive. RESULTS Ventilator-associated pneumonia was observed in 30 patients in the early tracheotomy group (14%; 95% confidence interval [CI], 10%-19%) and in 44 patients in the late tracheotomy group (21%; 95% CI, 15%-26%) (P = .07). During the 28 days immediately following randomization, the hazard ratio of developing ventilator-associated pneumonia was 0.66 (95% CI, 0.42-1.04), remaining connected to the ventilator was 0.70 (95% CI, 0.56-0.87), remaining in the ICU was 0.73 (95% CI, 0.55-0.97), and dying was 0.80 (95% CI, 0.56-1.15). CONCLUSION Among mechanically ventilated adult ICU patients, early tracheotomy compared with late tracheotomy did not result in statistically significant improvement in incidence of ventilator-associated pneumonia. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00262431.

Radiofrequency ablation versus ethanol injection for early hepatocellular carcinoma: A randomized controlled trial

Objective. To compare percutaneous ethanol injection (PEI), the standard approach which has been used for many years to treat early non-surgical hepatocellular carcinoma (HCC) in cirrhotic patients, and radiofrequency ablation (RFA), which has become an interesting alternative. Material and methods. A randomized trial was carried out on 139 cirrhotic patients in Child-Pugh classes A/B with 1–3 nodes of HCC (diameter 15–30 mm), for a total of 177 lesions. Patients were randomized to receive RFA (n=70) or PEI (n=69). The primary end-point was complete response (CR) 1 year after the percutaneous ablation of all HCC nodes identified at baseline. Secondary end-points were: early (30–50 days) CR, complications, survival and costs. Results. In an intention-to-treat analysis, 1-year CR was achieved in 46/70 (65.7%) and in 25/69 (36.2%) patients treated by RFA and PEI, respectively (p=0.0005). For lesions >20 mm in diameter, there was a larger CR rate in the RFA group (68.1% versus 26.3%). An early CR was obtained in 67/70 (95.7%) patients treated by RFA compared with 42/64 (65.6%) patients treated by PEI (p=0.0001). Complications occurred in 10 and 12 patients treated by RFA and PEI, respectively. The overall survival rate was not significantly different in the RFA versus PEI arm (adjusted hazard ratio=0.88, 95% CI: 0.50–1.53). There was an incremental health-care cost of 8286 € for each additional patient successfully treated by RFA. Conclusions. The 1-year CR rate after percutaneous treatment of early HCC was significantly better with RFA than with PEI but did not provide a clear survival advantage in cirrhotic patients.

A high positive predictive value algorithm using hospital administrative data identified incident cancer cases

OBJECTIVE We have developed and validated an algorithm based on Piedmont hospital discharge abstracts for ascertainment of incident cases of breast, colorectal, and lung cancer. STUDY DESIGN AND SETTING The algorithm training and validation sets were based on data from 2000 and 2001, respectively. The validation was carried out at an individual level by linkage of cases identified by the algorithm with cases in the Piedmont Cancer Registry diagnosed in 2001. RESULTS The sensitivity of the algorithm was higher for lung cancer (80.8%) than for breast (76.7%) and colorectal (72.4%) cancers. The positive predictive values were 78.7%, 87.9%, and 92.6% for lung, colorectal, and breast cancer, respectively. The high values for colorectal and breast cancers were due to the models ability to distinguish prevalent from incident cases and to the accuracy of surgery claims for case identification. CONCLUSIONS Given its moderate sensitivity, this algorithm is not intended to replace cancer registration, but it is a valuable tool to investigate other aspects of cancer surveillance. This method provides a valid study base for timely monitoring cancer practice and related outcomes, geographic and temporal variations, and costs.

Normal Glucose Values Are Associated With a Lower Risk of Mortality in Hospitalized Patients

OBJECTIVE—Hyperglycemia is a common condition in hospitalized patients. The aim of this study was to investigate the relationships between glycemia upon admission and mortality in a heterogeneous group of adult patients. RESEARCH DESIGN AND METHODS—The 3-year records released from a general hospital were associated with a plasma glucose dataset of its general laboratory. A matched case-control study was implemented (3,338 case-control subject pairs). All-patient refined diagnosis–related groups and the relative risk of death were the matching criteria. A multivariate conditional logistic regression model was used to evaluate the associations between death and glycemia. RESULTS—Higher in-hospital mortality was associated with hyperglycemia or hypoglycemia, whereas lower risk was observed for values between 78 and 101 mg/dl. CONCLUSIONS—Our data confirm the relation between glycemia upon admission and mortality and suggest that slightly increased or decreased plasma glucose can be linked with increased mortality risk.

Regression models for analyzing costs and their determinants in health care: an introductory review

OBJECTIVE This article aims to describe the various approaches in multivariable modelling of healthcare costs data and to synthesize the respective criticisms as proposed in the literature. METHODS We present regression methods suitable for the analysis of healthcare costs and then apply them to an experimental setting in cardiovascular treatment (COSTAMI study) and an observational setting in diabetes hospital care. RESULTS We show how methods can produce different results depending on the degree of matching between the underlying assumptions of each method and the specific characteristics of the healthcare problem. CONCLUSIONS The matching of healthcare cost models to the analytic objectives and characteristics of the data available to a study requires caution. The study results and interpretation can be heavily dependent on the choice of model with a real risk of spurious results and conclusions.

Experiences in US-Guided Percutaneous Radiofrequency Ablation of 44 Renal Tumors in 31 Patients: Analysis of Predictors for Complications and Technical Success

PurposePreliminary clinical studies have shown the feasibility, safety, and efficacy of radiofrequency thermal ablation (RFA) of renal tumors, but only a few have analyzed the prognostic factors for technical success and there are no long-term results. Our objective was to statistically evaluate our mid-term results of percutaneous US-guided RFA in order to define predictors for complications and technical success.MethodsWe selected for treatment 44 tumors in 31 patients (24 with renal cell carcinoma, 7 with hereditary tumors, 15 with a solitary kidney), up to 5 cm in diameter.ResultsEight adverse events occurred; 3 (6.8%) were major complications, successfully treated with interventional radiology procedures in 2 cases. Exophytic extension of the tumor was protective against complications (p = 0.040). Technical success was obtained in 38 lesions after one RFA session and in 39 (89%) after one more session, when possible. At the end of treatment, central extension was the only negative predictor for technical success (p = 0.007), while neither size >3 cm (p = 0.091) nor other prognostic factors were statistically significant.ConclusionUS-guided percutaneous RFA can be proposed for non-central renal tumors up to 5 cm, also in patients without surgical contraindications, thanks to a low incidence of complications and a high success rate. Randomized controlled trials versus surgery are now needed to investigate long-term comparative results.

Factors affecting pattern of care and survival in a population-based cohort of non-small-cell lung cancer incident cases

OBJECTIVE To analyze the role of sociodemographic factors as determinants of the initial pattern of care and survival in incident NSCLC cases. METHODS We linked 2298 incident NSCLC cases, identified by the Piedmont Cancer Registry of Turin (PCRT) with administrative health records to identify the initial pattern of care. Because stage of disease strongly influences pattern of care and prognosis of NSCLC, all the analyses were stratified according to stage (early and advanced). The association between the set of patients characteristics and the probability of accessing a specific pattern of care was analysed with a multivariable multinomial logistic regression model. Survival was analysed with the Cox proportional hazard model. RESULTS In the early stage group, presence of comorbidities, older age and low educational level were all associated with a lower probability of receiving surgery. These same factors, as well as being unmarried, were associated with higher probability of receiving other non-curative care only. The effects of comorbidities and low educational level as barriers to receiving more effective patterns of care were not relevant in the advanced stage group. When controlling for initial patterns of care, in the early stage group, an age older than 75 years and being unmarried were negative prognostic factors, while survival was completely independent from educational level. Among patients with an advanced stage of disease, only comorbidities had a negative impact on survival. CONCLUSION Appropriate lung cancer care is affected by sociodemographic factors. Greater attention to social and health programs is recommended to improve the timeliness of diagnosis, the staging of potentially resectable patients, and to implement more comprehensive multidisciplinary evaluations of those who may benefit from curative treatments.

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.

An economic evaluation of the optimal workload in treating surgical patients in a breast unit

A breast unit is a cancer centre specialised in the diagnosis and treatment of patients with breast cancer. The high level of specialised skills involved in running a breast unit makes it an expensive pattern of care. The European Society of Mastology (EUSOMA) recommends a minimum caseload of 150 cases sufficient to maintain expertise for each team member and to ensure cost-effective working of the breast unit. Specific economic analysis evaluating main diagnostic services (radiology and pathology) and treatment are needed. The present study assesses the activity level at which the breast unit represents good value for money in surgically-treated patients. Cost assessment is realised by defining a cost function according to the following assumptions: cost function input is personnel costs and technical equipment and output is the number of newly diagnosed cases of primary breast cancer admitted to the breast care unit each year. The increase from 50 new cancer cases per year to 100 will reduce average costs by almost 50%. Cost reduction is important up to a volume of 200 new cases per year. For economic investment to be justified, it is desirable that intake rises to at least 200 new cases per year. Our result is in-line with the EUSOMA recommendation.

The economic burden of caregiving on families of children and adolescents with cancer: A population‐based assessment

Childhood cancer represents a relevant economic burden on families. The preferred tool to investigate family expenditure is the retrospective questionnaire, which is subject to recall errors and selection bias. Therefore, in the present study the economic burden of caregiving on families of children and adolescents (0–19 years of age) with cancer was analysed using administrative data as an alternative to retrospective questionnaires.