Cost avoided in drugs derived from theparticipation of patients in oncologyclinical trials

Introduction: Cancer is the second leading cause of death globally. About one in six deaths is due to this disease. The economic impact of cancer is increasing and has a high prevalence leading to high economic burden for the Health System mainly related to oncologic pharmacotherapies. The objective of this study is to calculate pharmaceutical expenditure savings as a consequence of patient’s involvement in Oncology Clinical Trials.Material and methods: Retrospective observational study. In order to determine savings in oncology drugs, cancer treatments of patients participating in oncology clinical trials in April 2018 in a tertiary hospital in Spain were analyzed. Taking into account that the sponsor of the clinical trial provides the study medication free of charge, the costs savings were calculated comparing with the cost that would have supposed to treat the patient if they would have been received was standard regime for the type of tumor under study in clinical practice.Results: The cost avoided in the 50 oncology clinical trials analyzed was 1,564,943.59 euros. The average avoided cost per OCT was 31,298.87 euros, and the average avoided cost per patient was 10,096.41 euros.Conclusions: The participation of patients in oncology clinical trials provides an important economic saving, since it reduces the costs in the acquisition of medicines when they are provided free of charge by the sponsor of the study. (AU)

Introducción: El cáncer es la segunda causa de muerte a nivel mundial. Aproximadamente una de cada seis muertes se debe a esta enfermedad. El cáncer es una enfermedad de alta incidencia y el impacto derivado de la atención a pacientes oncológicos supone una importante carga económica para el Sistema Sanitario. El objetivo de este trabajo es calcular el coste evitado en medicamentos derivado de la participación de pacientes en Ensayos Clínicos de Oncología.Material y métodos: Estudio observacional retrospectivo. Se realiza un corte de datos en abril de 2018, se seleccionan todos los EECC activos en oncología y se incluyen los pacientes que habían participado en los mismos independientemente de la fecha de inclusión.Para determinar el coste evitado se calculó la diferencia entre el coste del esquema de tratamiento que el paciente está recibiendo dentro del EC con aportación gratuita de los medicamentos en investigación, y el coste que supondría el esquema de tratamiento que hubiese recibido en el supuesto de no haber participado en dicho EC.Resultados: El coste evitado en los 50 EECC analizados fue de 1.564.943,59 euros. El coste evitado medio por EC fue de 31.298,87 euros, y el coste evitado medio por paciente fue de 10.096,41 euros.Conclusiones: La participación de pacientes en EECC de oncología proporciona un importante ahorro económico, ya que reduce los costos en la adquisición de medicamentos cuando son proporcionados gratuitamente por el promotor del estudio. (AU)

Assessing the effect of catchment characteristics to enhanced coagulation in drinking water treatment: RSM models and sensitivity analysis.

Coagulation is the main process for removing natural organic matter (NOM), considered to be the major disinfection by-products (DBPs) precursor in drinking water production. In this work, k-means clusters analysis were used to classify influent waters from two different surface drinking water treatment plants (DWTPs) located in the Mediterranean region. From this, enhanced coagulation models based on response surface methodology (RSM) were then developed to optimise coagulation at two water catchments (river and reservoir). The cluster analysis classified the water quality of the raw waters into two groups related to baseline and peak organic loads. The developed enhanced coagulation models were based on the turbidity, total organic carbon (TOC) and UV254 removals. Sensitivity analysis applied to the models (after predictors selection) determined the factors relative individual contributions for each DWTP scenario. Then, profile plots for enhanced coagulation were studied to identify the optimal levels for each case. Models mean R2 were 0.85 and 0.86 in baseline and 0.85 and 0.84 in peak scenario for river and reservoir catchments, respectively. Results of this study indicate that the surface water quality variation in river DWTP is seasonal and is expressed by an increase of turbidity, while in the reservoir DWTP is related to extreme weather events showing high levels of dissolved organic load (TOC and UV254). During baseline cases, where raw waters present low levels of organics, the three factors optimal adjustment should be ensured to optimise coagulation. Then, during peak scenarios, where influent waters present high organics, the optimal for enhanced coagulation relies on the correct adjustment of Cd. The presented work provides models for drinking water production aimed to propose the optimum conditions for enhanced coagulation, considering the influent water characteristics under different weather conditions.

Use of a closed-system drug transfer device (PhaSeal) and impact on preparation time.

PhaSeal is a closed-system drug transfer device which has demonstrated to protect against occupational exposure to antineoplastic agents. Our aim was to assess the impact of the incorporation of PhaSeal on the processing time of chemotherapy. The study was a prospective simulation study which compared the processing times with the traditional open-system technique and using the closed-transfer system. Four experienced pharmacy technicians prepared six batches with each method simulating simple chemotherapy admixture operations. We compared the mean times obtained by student's t test and evaluated the "learning effect" between days by ANOVA. The average percentage of time saving with PhaSeal was 31.7% (time per batch [mean +/- SD] 6.44+0.73 vs. 9.44+0.98 minutes). Mean difference was statistically significant (3.0 min IC95% 2.50-3.50; p>0.0001). No significant learning curve effect was detected. The BD Medical/Carmel Pharma PhaSeal system, in addition to its protective properties, is able to save time in the elaboration process which leads to organization advantages for hospital pharmacy services.

Conservative treatment of ipsilateral fractures of the scapula and clavicle.

A review is made of 16 cases of ipsilateral fractures of the scapula and clavicle treated conservatively. After a mean follow-up of 7.5 years, the functional results were good or excellent in 92% of the cases.

Congenital brachymetatarsia: three cases.

We report on three cases with congenital brachymetatarsia, one with bilateral affectation, together with the results of a lengthening of the short metatarsal bones by progressive axial distraction using an external minifixator. The method proved to be easy to implement, permitting immediate functionality of the ankle and early load bearing. The immediate results (cosmetic) and later findings (functional) were excellent in all three cases.

Clinical and ultrastructural analysis of failures in chemonucleolysis.

A series of 12 patients with failed chemonucleolysis were analyzed to determine the various causes of such failures. The ultrastructural findings observed in laminectomy specimens did not account for the failure in the enzyme treatment. The findings suggested deficient cellular nutrition secondary to enzymatic histolysis of the nucleus pulposus.

Hip fracture in the elderly in Spain. Incidence 1977-88 in the province of Salamanca.

We recorded the incidence of fractures of the proximal end of the femur in the province of Salamanca, Spain, 1977-88. Based on age-specific survival estimates, the probability of suffering a hip fracture after 50 years of age in women was 7 percent and in men 2 percent, i.e., substantially lower than in Northern Europe or U.S.A.

Post-chemonucleolysis computed tomographic findings.

The CT findings observed 6 months and 2 years after chemonucleolysis in 50 and 34 patients are reported. Emphasis is placed on the persistence of the hernia image in nearly 70% of the cases, together with an increase in degenerative intradiscal signs and degeneration of the facet joints; however, this did not lead to poor results 2 years after chemonucleolysis.

[Comparative study between conservative orthopedic therapy and intramedullary osteosynthesis of diaphyseal tibial fractures]. / Vergleichende Studie zwischen konservativer orthopädischer Therapie und der intramedullären Osteosynthese diaphysärer Tibiafrakturen.

The authors present the results obtained in a series of 275 tibial shaft fractures, 216 of which were treated by a functional orthopaedic procedure and 59 with different kinds of nailing techniques. The results are evaluated according to the criteria established by Johner and Wruhs. "Good" results were obtained with both kinds of treatment; "excellent" results were slightly more frequent with nailing techniques, owing to better alignment and a lesser degree of shortening in the fractures, although the residual deformities after the functional orthopaedic treatment were tolerable.

Migration of Kirschner wires into the mediastinum after stabilization of sterno-clavicular lesions. A report of two cases.

The authors describe two cases of intrathoracic migration of Kirschner wires used for fixation of unstable Allman grade III sternoclavicular dislocation. The wires continue their migration after 10 years despite the risk and the need to treat such complications.

Orthopaedic treatment in tibial diaphyseal fractures. Risk factors affecting union.

A retrospective of 216 tibial fractures treated orthopedically was carried out. The aim was to analyze a set of clinicobiological parameters that owing to their assumed action on the physiological model of consolidation can be considered as risk factors to be taken into account in all kinds of orthopedic treatment, because they may lead to a lengthening of the normal consolidation time of the fracture. The variables analyzed were the following: type of immobilization, causative agent of the fracture, location of the focus of the fibular fracture, initial displacement, degree of conminution, type of wound, type of fracture, appearance of radiologically observable callus, commencement of weight-bearing, post-fracture hematoma, secondary displacement, and infection of soft tissues. In the particular case of immobilization by an ischiopedic plaster cast, the following parameters showed a greater degree of prognostic significance: initial displacement, secondary displacement, and age.

Carbon and polyester fibers as a scaffold for bone repair. Studies of segmentary implants in the rabbit radius.

To determine the function in the repair of bone defects, implants of carbon and polyester fibers of comparable dimensions were used to replace a 2-cm long segment of the radius of 29 rabbits. The healing process was analyzed by scintigraphic, radiographic, and histologic methods after periods of 15-90 days, comparing the results with a control group without implants. In the rabbit, carbon and polyester fibers did not induce repair of bone defects, although they did permit invasion of the implant during the later stages.

Calcitonin, estradiol, and hydroxyproline as parameters in the early diagnosis of involutional osteoporosis. The importance of the "second calcitonin phenomenon".

Bone metabolism was studied in a group of 92 subjects. A greater age-related decrease in calcitonin and estradiol concentrations exists in women than in men, though this difference was not significant; it was significant, however, when the values of the three different groups of women were compared. We present what we have called the second calcitonin phenomenon, that is, a highly significant difference in women between a second basal calcitonin level and the primary admission value. In the calcium infusion test, men considered to be osteoporotic showed a deceleration in the rapid loss of reserve calcitonin deposits.

[Reconstructive surgery using a massive prosthesis in loosening of a hip prosthesis]. / Chirurgie de reconstruction par prothèse massive dans le descellement d'endoprothèses de la hanche.

Thirteen cases with loosening of THR treated by a massive prosthesis are reviewed. In previous years, with more conservative surgery, the loss of bone stock was most important. The results after a long follow-up were satisfactory. This was a desperate procedure during a period without a bone-bank. Despite the major problems with failure of this procedure, the author still recommends it in elderly patients who need early mobilization or when the use of a bank-bone is not possible.

An experimental study of the redistribution of patellofemoral pressures by the anterior displacement of the anterior tuberosity of the tibia.

Using a series of miniature piezoelectric transducers constructed by the authors, a study was made of the effect of anterior displacement of the tuberosity of the tibia on the distribution of pressures in the patellofemoral joint. Proportionally, the most efficient displacements are those set at 1 cm; after this, and as advancement of the tuberosity is increased, the overall pressure continues to decrease progressively (although more slowly) because there are zones that, according to their situation, receive increased instead of decreased pressures. Consequently, values even higher than those of the original situation are reached. This is the case of the proximal part of the patella, particularly on its lateral facet. This situation can affect the results in cases where the lesion is preferentially located on the proximal part. In these cases it may be enough to advance 1 cm with which overall decompressions close to 50% of the pressure that initially affected the patellofemoral joint are obtained. In very evolved cases or when the lesions are located centrally or distally, it may be worthwhile to advance maximally in spite of the possible complications, seeking the greatest decompression effect that intense advancements can achieve.

Sternoclavicular dislocation. Treatment and complications.

Based on Allman's classification, the authors conducted a critical study on the results of treatment of 17 sternoclavicular dislocations, 14 anterior and 3 posterior. They propose conservative treatment for subluxations and operative treatment for total dislocations, particularly when posterior. Tomography was required for precise diagnosis. The advantages of open reduction are stressed and the complication of intra-thoracic migration of crossed Kirschner wires used to stabilise reduction and capsular suturing is described.