Second-line treatment in advanced gastric cancer : Data from the Spanish AGAMENON registry

Second-line treatments boost overall survival in advanced gastric cancer (AGC). However, there is a paucity of information as to patterns of use and the results achieved in actual clinical practice. The study population comprised patients with AGC in the AGAMENON registry who had received second-line. The objective was to describe the pattern of second-line therapies administered, progression-free survival following second-line (PFS-2), and post-progression survival since first-line (PPS). 2311 cases with 2066 progression events since first-line (89.3%) were recorded; 245 (10.6%) patients died during first-line treatment and 1326/2066 (64.1%) received a second-line. Median PFS-2 and PPS were 3.1 (95% CI, 2.9-3.3) and 5.8 months (5.5-6.3), respectively. The most widely used strategies were monoCT (56.9%), polyCT (15.0%), ramucirumab+CT (12.6%), platinum-reintroduction (8.3%), trastuzumab+CT (6.1%), and ramucirumab (1.1%). PFS-2/PPS medians gradually increased in monoCT, 2.6/5.1 months; polyCT 3.4/6.3 months; ramucirumab+CT, 4.1/6.5 months; platinum-reintroduction, 4.2/6.7 months, and for the HER2+ subgroup in particular, trastuzumab+CT, 5.2/11.7 months. Correlation between PFS since first-line and OS was moderate in the series as a whole (Kendall's τ = 0.613), lower in those subjects who received second-line (Kendall's τ = 0.539), especially with ramucirumab+CT (Kendall's τ = 0.413). This analysis reveals the diversity in second-line treatment for AGC, highlighting the effectiveness of paclitaxel-ramucirumab and, for a selected subgroup of patients, platinum reintroduction; both strategies endorsed by recent clinical guidelines

Full Outline of UnResponsiveness (FOUR) scale: Translation and linguistic and cultural adaptation of the Russian language version

Introduction: The assessment of the level of consciousness in patients with acute brain injury is a mandatory first step of neurological examination. There is a need for clinical scales which allow to assess the level of wakefulness and degree of patient non-responsiveness in 2-3 minutes. The Full Outline of UnResponsiveness (FOUR) scale is an optimal tool for such clinical assessment, which focuses on eye response, motor response, brainstem reflexes, and respiratory pattern. The absence of an officially translated and validated version impedes the use of FOUR scale in Russia, while the use of non-validated clinical scales carries a risk of erroneous diagnosis and reduces the quality and information value of research studies. Study aim: to develop an official Russian language version of the FOUR scale, taking into account its linguistic and cultural characteristics as part of the validation st udy. Materials and methods: The first stage of the validation process was completed, consisting of the linguistic and cultural adaptation of the FOUR scale. Medical professionals (Russian and English native speakers) performed forward and back translations of the original scale. The developed version then underwent review by the Expert Commission, which included a linguist, neurologists, anaesthesiologists and intensive care specialists. The next step was a pilot test of the scale. Results: The main difficulties in the translated text of the scale were solved during the first meeting of the Expert Commission. Then, taking into account the inclusion and exclusion criteria, a pilot test was performed by assessing 15 patients with the developed version of the FOUR scale. The statistics of this cohort are presented. Investigators had no difficulties in understanding and interpreting the scale instructions during the pilot test. Based on the results, the final version of the scale was adopted. The Russian version of the scale text with instructions and illustrations is presented in this paper. Conclusion: Translation, linguistic and cultural adaptation of the FOUR scale was conducted at the Research Centre of Neurology (Moscow, Russia). For the first time, the Russian version of the scale is officially presented and recommended for widespread use in clinical and research practice in Russia and other Russian-speaking countries based on the results of pilot testing. The next publication will present the results of the evaluation of psychometric properties (reliability, sensitivity, etc.) of this version of the scale. © 2019 Sovero Press Publishing House. All rights reserved

Comorbidities Coma Scale (CoCoS): Linguistic and Cultural Adaptation of the Russian-Language Version

Identification of complications and control of comorbidities are essential in monitoring the patients with chronic disorders of consciousness and predicting their outcomes. The researchers of the Department of Biotechnological and Applied Clinical Sciences of the University of L'Aquila (Italy) developed the Comorbidities Coma Scale (CoCoS) for a comprehensive assessment of such patients. Lack of an officially validated version of the scale hampers its use in Russia, while using versions which have not been completely validated prevents clinicians from obtaining reliable results when examining patients with chronic disorders of consciousness. Aim. To develop the official Russian language version of the Comorbidities Coma Scale, considering various linguistic and cultural parameters, as a part of the 1st stage of the validation study. Material and methods. The first stage of validation was completed: direct and reverse translation of the scale was performed by two independent medical translators. The translated version was assessed by an expert board including an expert translator, neurologists, and critical care specialists. Pilot test and two meetings of the expert board, before and after testing, were arranged to assess the results and approve the final Russian version of the scale. Results. During the first meeting of the expert board, corrections were made in the Russian language version of the scale in terms of language and cultural adaptation. Pilot testing was carried out based on the inclusion and exclusion criteria. The researchers had no difficulties in understanding and interpreting the instructions for the scale. The second meeting of the expert board was held thereupon, and the final version of the Russian language version of the scale was adopted, which is available on the website of the Center for Validation of Health Status Questionnaires and Scales of the Research Center of Neurology. Conclusion. The first stage of validation, i. e., linguistic and cultural adaptation, was carried out at the Research Center of Neurology (Moscow, Russia). For the first time, the Russian version of the scale for assessing comorbidities in patients with chronic disorders of consciousness was presented and approved for the practical use. The future publications will address the psychometric results of the scale such as sensitivity, validity, reliability. © 2022, V.A. Negovsky Research Institute of General Reanimatology. All rights reserved

Glasgow coma scale: Linguistic-cultural adaptation of the Russian version [Шкала комы Глазго (Glasgow Coma Scale, GCS): лингвокультурная адаптация русскоязычной версии]

INTRODUCTION Determination of the degree of depression of consciousness in patients with brain damage upon admission to the intensive care unit and intensive therapy is a primary task. In order to carry out a quick and at the same time sufficiently complete assessment of this kind, in 1974 neurosurgeons Graham Teasdale and Bryan Jennett from the University of Glasgow developed an algorithm consisting of a sequential series of tests in the form of eye opening, speech and motor responses, called Glasgow Coma Scale. This scale has received worldwide recognition and for many decades has been the main one for determining the state of consciousness in the most severe patients with brain damage. The absence of a validated version of this scale complicates its application in Russia, and the use of currently available versions that have not passed all the necessary stages of validation distorts the originally intended meaning of the scale and does not allow obtaining reliable clinical results when examining patients with acute impairment of consciousness. AIM OF STUDY Development of the official Russianlanguage version of the Glasgow Coma Scale, taking into account linguistic and cultural characteristics (1st stage of the validation study). MATeRIAL AND MeTHODS The staff of Center for Validation of Health Status Questionnaires and Scales in Russia, Research Center of Neurology obtained consent from G. Teasdale to validate Glasgow Coma Scale in Russia. Two Russianspeaking professional certified translators in the field of medicine performed a direct translation of the original Englishlanguage scale, and a reverse translation was carried out by native speakers with a medical education. Pilot study was performed in 15 patients with acute impairment of consciousness, two meetings of the expert committee were held (before and after pilot study). ReSULTS Based on the results of the first meeting of the expert commission, a linguistic and cultural adaptation of the text of the scale was carried out. During the pilot testing of the researchers did not have difficulties in understanding and interpreting instructions. As a result, the second meeting of the expert commission was held and the final Russianlanguage version was approved, which is presented in this article and is available on the website of Center for Validation of Health Status Questionnaires and Scales in Russia, Research Center of Neurology. CONCLUSION For the first time, the Russian language version of the Glasgow Coma Scale was officially presented and recommended for use both in clinical and research practice in Russia and other Russian speaking countries. The next publication will highlight the result of assessing the psychometric properties (reproducibility, interexpert agreement and sensitivity) of the Russianlanguage version of the scale. © 2021 Sklifosovsky Research Institute for Emergency Medicine. All rights reserved