Clinical and cost outcomes of a polyethylene glycol (PEG)-coated patch versus drainage after axillary lymph node dissection in breast cancer: results from a multicentre randomized clinical trial.

BACKGROUND: The aim of this study was to compare the clinical outcomes between breast cancer patients who underwent axillary lymph node dissection with postoperative management using a polyethylene glycol-coated patch versus axillary drainage. The direct costs associated with both postoperative management strategies were also evaluated. METHODS: This was a multicentre RCT in women with breast cancer who underwent axillary lymph node dissection (ClinicalTrials.gov identifier: NCT04487561). Patients were randomly assigned (1 : 1) to receive either drainage or a polyethylene glycol-coated patch as postoperative management. The primary endpoints were the need for an emergency department visit for any event related to the surgery and the rate of seroma development. RESULTS: A total of 227 patients were included , 115 in the patch group (50.7 per cent) and 112 (29.4 per cent ) in the drainage group. The incidence of emergency department visits was significantly greater for patients with drainage versus a polyethylene glycol-coated patch (incidence rate difference 26.1 per cent, 95 per cent c.i. 14.5 to 37.7 per cent; P < 0.001). Conversely, the seroma rate was significantly higher in the polyethylene glycol-coated patch group (incidence rate difference 22.8 per cent, 95 per cent c.i. 6.7 to 38.9 per cent; P < 0.0055). Compared with drainage, using a polyethylene glycol-coated patch resulted in cost savings of €100.41 per patient. An incremental cost-effectiveness ratio analysis found that drainage was associated with an incremental cost-effectiveness ratio of €7594.4 for no need for hospital admission and €491.7 for no need for an emergency department visit. CONCLUSION: Compared with patients who received drainage after axillary lymph node dissection, the use of a polyethylene glycol-coated patch resulted in a higher rate of seroma, but a lower number of postoperative outpatient or emergency department visits and thus a reduction in overall costs.

Influence of Transfer Entropy in the Short-Term Prediction of Financial Time Series Using an ∊-Machine.

Predicting the values of a financial time series is mainly a function of its price history, which depends on several factors, internal and external. With this history, it is possible to build an ∊-machine for predicting the financial time series. This work proposes considering the influence of a financial series through the transfer of entropy when the values of the other financial series are known. A method is proposed that considers the transfer of entropy for breaking the ties that occur when calculating the prediction with the ∊-machine. This analysis is carried out using data from six financial series: two American, the S&P 500 and the Nasdaq; two Asian, the Hang Seng and the Nikkei 225; and two European, the CAC 40 and the DAX. This work shows that it is possible to influence the prediction of the closing value of a series if the value of the influencing series is known. This work showed that the series that transfer the most information through entropy transfer are the American S&P 500 and Nasdaq, followed by the European DAX and CAC 40, and finally the Asian Nikkei 225 and Hang Seng.

Is Axillary Assessment of Ductal Carcinoma In Situ of the Breast Necessary in All Cases?

BACKGROUND: Staging of the axilla in women with ductal carcinoma in situ (DCIS) is a point of controversy. We aimed to assess whether there is a group of patients in whom axillary assessment can be avoided and whether the likelihood of underdiagnosis of infiltrating carcinoma is sufficient to justify this evaluation. MATERIALS AND METHODS: This was a multicenter, prospective, observational study of patients who were operated on between 2008 and 2018 in three Spanish hospitals, with a diagnosis by radiological or excisional biopsy of DCIS and clinically and radiologically negative axilla. RESULTS: A total of 530 patients with a preoperative diagnosis of DCIS were studied. An axillary assessment was performed in 77% of the patients. In 397 patients, selective sentinel lymph node biopsy was performed. Axillary involvement was found in 7.2% of all patients, which dropped to 2.15% if we only included DCIS diagnosed after a definitive anatomical pathology analysis. Underdiagnosis was correlated with the type of biopsy performed: the risk was 1.34 times as high if the biopsy was performed with a core needle. The risk of lymph node metastasis was higher when there was lymphovascular invasion and when mastectomy was performed. CONCLUSIONS: We propose an axilla management algorithm in patients with a preoperative diagnosis of DCIS. The patients who would benefit from sentinel lymph node biopsy would be those who are not candidates for breast-conserving surgery, those with a BIRADS 5 lesion biopsied by core-needle biopsy, and those whose definitive diagnosis is lymphovascular invasion.

Rectal advancement flaps for the treatment of transphincteric perianal fistulas: a three-dimensional endoanal ultrasound and quality of life assessment.

This study quantifies the damage to the internal anal sphincter (IAS) after a rectal mucosal advancement flap for a high transphincteric fistula in 16 patients using 3D-endoanal ultrasound. This was correlated with postoperative incontinence and quality of life scores. The median length of involved IAS preoperatively was 50 % (20-100) and 93.72 % for EAS (47.4-100 %). IAS division did not influence continence (p > 0.05). Continence deteriorated between the pre-, postoperative (p = 0.014) and six-month follow-up (p = 0.005), with no significant differences after one year (p > 0.05). The FIQOL score and SF-36 deteriorated initially, with recovery in all domains except for mental health after one year. Three fistulas recurred (18.75 %).

Cost analysis of the management of brain metastases in patients with advanced ALK+ NSCLC: alectinib versus crizotinib.

AIM: To estimate management cost of NSCLC ALK+ patients with and without brain metastasis (BM), and to compare annual costs in patients treated with alectinib or crizotinib. METHODS: Management cost/year (€ 2018) in patients with and without BM was estimated with disaggregated resource consumption provided by local oncologists, including medical visits, hospitalizations, diagnostic/laboratory tests, imaging techniques and surgical procedures. The comparison of costs/year with alectinib and crizotinib, considered the cumulative 12-month incidence of BM in ALEX trial (9.4 and 41.4%, respectively). RESULTS: Management cost was €6173.42/patient-year without BM and €21,637.50/patient-year with BM. With alectinib, average cost/patient was lower than crizotinib (€4948.51/patient-year). CONCLUSION: Prevention of BM with alectinib may result in reductions of cost/year in the management of advanced ALK+ NSCLC.

Cost-Effectiveness and Cost-Utility Analysis of Ingenol Mebutate Versus Diclofenac 3% and Imiquimod 5% in the Treatment of Actinic Keratosis in Spain. / Análisis de coste-efectividad y coste-utilidad de ingenol mebutato versus diclofenaco 3% e imiquimod 5% en el tratamiento de la queratosis actínica en España.

OBJECTIVE: To perform a cost-effectiveness and cost-utility analysis of ingenol mebutate in the treatment of actinic keratosis in Spain. METHODS: We used an adapted Markov model to simulate outcomes in a cohort of patients (mean age, 73 years) with actinic keratosis over a 5-year period. The comparators were diclofenac 3% and imiquimod 5%. The analysis was performed from the perspective of the Spanish National Health System based on direct costs (2015 retail price plus value added tax less the mandatory discount). A panel of experts estimated resources, taking unit costs from national databases. An annual discount rate of 3% was applied. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: The effectiveness of ingenol mebutate-with 0.192 and 0.129 more clearances gained in treatments for face and scalp lesions and trunk and extremity lesions, respectively-was superior to diclofenac's. The total costs of treatment with ingenol mebutate were lower at € 551.50 (face and scalp) and € 622.27 (trunk and extremities) than the respective costs with diclofenac (€ 849.11 and € 844.93). The incremental cost-effectiveness and cost-utility ratios showed that ingenol mebutate was a dominant strategy vs diclofenac. Ingenol mebutate also proved to be more effective than imiquimod, based on 0.535 and 0.503 additional clearances, and total costs of € 551.50 and € 527.89 for the two drugs, respectively. The resulting incremental cost-effectiveness ratio was € 728.64 per clearance gained with ingenol mebutate vs imiquimod. CONCLUSIONS: Ingenol mebutate was a dominant treatment option vs diclofenac and was efficient vs imiquimod (i.e., more effective at a higher cost, achieving an incremental cost-utility ratio of<€30000/quality-adjusted life-years).

Efficacy and cost-effectiveness of the UltraCision harmonic scalpel in thyroid surgery: an analysis of 200 cases in a randomized trial.

BACKGROUND: Thyroid surgery technique has undergone very few changes in the last century. The UltraCision harmonic scalpel (UHS) (Smithfield, RI) has been widely used in laparoscopic surgery and is documented to be safe and fast for cutting and coagulating tissue. We studied whether the use of the UHS could have advantages in thyroid surgery in terms of operative time, length of hospitalization, morbidity, and general costs. METHOD: Our study was a prospective randomized trial of thyroidectomies and lobectomies performed for benign thyroid diseases in an endocrine surgery unit between February 2001 and July 2002. Patients were randomized in two groups: group A (n=100) underwent thyroidectomy using UHS and group B (n=100) with the conventional clamp-and-tie technique. Main outcome measures were demographics, operating time, length of hospitalization, intra- and postoperative complications, sequelae, and general costs. We used the unpaired 2-tailed Student's t test and the chi2 test to compare the series. RESULTS: The two groups were similar in age and sex. Mean +/- SD operative time was shorter in the UHS group compared with the conventional technique group for both lobectomy (61 +/- 06 vs. 78 +/- 10 minutes) and total thyroidectomy (86 +/- 20 vs. 101 +/- 16 minutes). Length of hospitalization was similar in both groups (1.07 vs. 1.15 days). We did not find statistical differences between the two techniques regarding transient postoperative complications. There were no deaths, no blood transfusions, no intraoperative complications, and no postoperative definitive sequelae. The global charges for every patient were significantly less in the UHS group (985.77 +/- 107.08 euro vs. 1148.40 +/- 153.25 euro). CONCLUSION: The use of ultrasonically activated shears resulted in a reduction of 15-20% in operative time and was cost-effective compared to the conventional technique group.

Cost-effectiveness of laparoscopic vs open adrenalectomy: small savings in an expensive process.

BACKGROUND AND PURPOSE: Nowadays, laparoscopy has become the approach of choice for adrenalectomy, especially in cases of benign tumors <6 cm. The authors have studied, in a retrospective trial, two groups of patients who have undergone an adrenalectomy: 10 consecutive patients operated on by an open approach and 10 consecutive patients operated on by laparoscopy. METHODS: Laparoscopic adrenalectomies were performed via a transabdominal lateral approach, whereas open adrenalectomies were performed via an anterior transabdominal or posterior retroperitoneal approach. Clinical outcomes were recorded, and special attention was paid to the costs of both techniques, collecting economic data from the costs in outpatient visits, blood and urine tests, diagnostic imaging, hospital admissions prior to surgery, hospital admission for surgery, and surgical expenses. RESULTS: Operative time (110 vs 123 minutes), length of postoperative stay (3.7 vs 5.8 days), and time to oral intake (1 vs 2 days) were significantly lower in the laparoscopic group. From the economic point of view, however, there were no significant differences between laparoscopic and open groups (6,306 vs 7,581), and only surgical inhospital stay costs were significantly lower in the laparoscopic series (742 vs 1,191). All the costs generated by surgery (hospital admission for surgery plus surgical expenses) were smaller in the laparoscopic group but constituted only a small part of the general expenses for these patients. The more expensive part of the budget for every patient was the hospital admissions prior to surgery for diagnosis or preoperative treatment. CONCLUSION: Laparoscopy is a safe and comfortable approach for adrenalectomy and should be the technique of choice. From the economic point of view, laparoscopic adrenalectomy is cheaper than open adrenalectomy, but in all cases, surgical costs are only a minimal part of the budget, and the greater savings must come from the reduction in the presurgical diagnostic process.