Factors associated with recruitment success in the phase 2a study of aztreonam-avibactam development programme: a descriptive qualitative analysis among sites in Spain.

OBJECTIVE: Successful clinical trials are subject to recruitment. Recently, the REJUVENATE trial, a prospective phase 2a open-label, single-arm interventional clinical trial conducted within the Innovative Medicines Initiative-supported Combatting Bacterial Resistance in Europe-Carbapenem Resistance project, was published, with 85% of the recruitment performed in Spain. We analysed the recruitment success in this trial by establishing a model of recruitment practice. METHODS: A descriptive qualitative study was performed from May 2016 to October 2017 at 10 participating Spanish centres. Data were extracted from: (1) feasibility questionnaires to assess the centre's potential for patient enrolment; (2) delegation of responsibility records; (3) pre-screening records including an anonymised list of potentially eligible and (4) screening and enrolment records. A descriptive analysis of the features was performed by the participating centre. Pearson's and Spearman's correlation coefficients were calculated to determine factors of recruitment success. RESULTS: The highest recruitment rate was observed in Hospitals 3 and 6 (58.8 and 47.0 patients per month, respectively). All the study teams were multidisciplinary with a median of 15 members (range: 7-22). Only Hospitals 3, 5 and 6 had dedicated nursing staff appointed exclusively to this study. Moreover, in those three hospitals and in Hospital 9, the study coordinator performed exclusive functions as a research planner, and did not assume these functions for the other hospitals. The univariate analysis showed a significant association between recruitment success and months of recruitment (p=0.024), number of staff (p<0.001), higher number of pharmacists (p=0.005), infectious disease specialists (p<0.001), the presence of microbiologist in the research team (p=0.018) and specifically dedicated nursing staff (p=0.036). CONCLUSIONS: The existence of broad multidisciplinary teams with staff dedicated exclusively to the study as well as the implementation of a well-designed local patient assessment strategy were the essential optimisation factors for recruitment success in Spain. TRIAL REGISTRATION NUMBER: NCT02655419; EudraCT 2015-002726-39; analysis of pre-screened patients.

Resultados de lesión del nervio laríngeo recurrente en cirugía de tiroides con el uso del neuroestimulador.

BACKGROUND: Intermittent intraoperative neuromonitoring of the recurrent laryngeal nerve is the ideal complement in thyroid surgeries, decreasing thyroid injuries. OBJECTIVE: To analyze the prevalence of recurrent laryngeal nerve injuries with the use and without the use of neuromonitoring in thyroid surgery. METHOD: Observational, descriptive and retrospective study, in which a total of 571 patients were included between the years 2012-2018. Of which 180 neuromonitoring was used and 391 were not used. RESULTS: Of the 180 patients who underwent total thyroidectomy with the use of neuromonitoring, we had a total of 8 (4.4%) transient paralysis and 2 (1.1%) definitive. Without the use of neuromonitoring we obtain 12 (3%) transient paralysis and 7 (1.85%) definitive. CONCLUSIONS: We believe that the use of neuromonitoring complementary to surgery should be used routinely to the usual technique. And we also obtain significant results regarding the reduction of recurrent laryngeal nerve injuries with the use of intraoperative neuromonitoring.

ANTECEDENTES: La neuromonitorización intraoperatoria intermitente del nervio laríngeo recurrente es el complemento ideal en las cirugías tiroideas, ya que disminuye las lesiones. OBJETIVO: Analizar la prevalencia de lesiones del nervio laríngeo recurrente con y sin el uso de neuromonitorización en cirugía de tiroides. MÉTODO: Estudio observacional, descriptivo y retrospectivo, en el que se incluyeron 571 pacientes entre los años 2012 y 2018. De ellos, en 180 se utilizó neuromonitorización y en 391 no. RESULTADOS: De los 180 pacientes que se sometieron a tiroidectomía total con neuromonitorización hubo 8 (4.4%) parálisis transitorias y 2 (1.1%) parálisis definitivas. Sin el uso de neuromonitorización hubo 12 (3%) parálisis transitorias y 7 (1.85%) definitivas. CONCLUSIONES: Creemos que la neuromonitorización debe usarse sistemáticamente con la técnica habitual. Obtenemos resultados significativos con respecto a la reducción de las lesiones del nervio laríngeo recurrente con el uso de neuromonitorización intraoperatoria.

Contributions of fluorescence to endocrine surgery. / Aportaciones de la fluorescencia a la cirugía endocrina.

The use of fluorescence in surgery has expanded and become widespread in recent years, which has led to a real technological phenomenon with the emergence of devices adapted for use in laparoscopic and robotic approaches. Fluorescence-guided surgery in the field of endocrine surgery is also on the rise. More and more articles describe its use in surgery of the thyroid, parathyroid and adrenal glands, although the series are still modest in size and protocols have not been standardized. There are currently several developing areas for the application of fluorescence in endocrine surgery, including the use of fluorescence with indocyanine green in adrenal gland surgery, the identification and prediction of parathyroid perfusion with indocyanine green, and autofluorescence of the parathyroid glands. The objective of this article is to review the current applications of fluorescence in endocrine surgery.