Stres na radu i zdravlje medicinskih sestara u jedinicama intenzivne njege u Srbiji

The aim of this study was to identify and analyse professional stressors, evaluate the level of stress in nurses in Intensive Care Units (ICU), and assess the correlation between the perception of stress and psychological and somatic symptoms or diseases shown by nurses. The research, designed as a crosssectional study, was carried out in the Intensive Care Units (ICU), in health centres in Serbia. The sample population encompassed 1000 nurses. Expanded Nursing Stress Scale (ENSS) was used as the research instrument. ENSS revealed a valid metric characteristic within our sample population. Nurses from ICUs rated situations involving physical and psychological working environments as the most stressful ones, whereas situations related to social working environment were described as less stressful; however, the differences in the perception of stressfulness of these environments were minor. Socio-demographic determinants of the participants (age, marital status and education level) significantly affected the perception of stress at work. Significant differences in the perception of stressfulness of particular stress factors were observed among nurses with respect to psychological and somatic symptoms (such as headache, insomnia, fatigue, despair, lower back pain, mood swings etc.) and certain diseases (such as hypertension, myocardial infarction, stroke, diabetes mellitus etc). In view of permanent escalation of professional stressors, creating a supportive working environment is essential for positive health outcomes, prevention of job-related diseases and better protection of already ill nurses.Cilj je ovoga rada bio identifi cirati i analizirati profesionalne stresore, procijeniti razinu stresa kod medicinskih sestara u jedinicama intenzivne njege te procijeniti korelaciju između percepcije stresa i prisutnosti psiholoških i somatskih simptoma ili bolesti kod medicinskih sestara. Istraživanje je provedeno u obliku studije presjeka u Jedinicama intenzivne njege u zdravstvenim centrima u Srbiji. Uzorak se sastojao od 1000 medicinskih sestara-tehničara. Za procjenu i analizu profesionalnih stresora korišten je upitnik Expanded Nursing Stress Scale (ENSS), koji je pokazao validne metrijske karakteristike na našoj ispitanoj populaciji. Medicinske sestre u Jedinicama intenzivne njege ocijenile su situacije iz fizičkoga i psihološkoga radnog okruženja kao izrazito opterećujuće, a situacije iz socijalnoga radnog okruženja kao manje opterećujuće. Razlika u percepciji stresogenosti navedenih radnih okruženja nije bila statistički značajna. Sociodemografske determinante ispitanika (dob, bračno stanje i stupanj obrazovanja) značajno utječu na percepciju stresa na radnom mjestu. Utvrđena je statistički značajna razlika u opažanju stresogenosti pojedinih stresnih situacija na radnom mjestu između medicinskih sestara u odnosu na postojanje psihosomatskih simptoma (kao što su glavobolja, nesanica, umor, očaj, bol u leđima, česte promjene raspoloženja) ili određenih bolesti (kao što su povišena hipertenzija, infarkt miokarda, cerebrovaskularni inzult, šećerna bolest). Zbog sve izraženije prisutnosti profesionalnih stresora nužno je poduzeti određene strateške mjere kod medicinskih sestara u Jedinicama intenzivne njege. Strateške mjere podrazumijevaju unaprjeđenje psihosocijalne radne klime, što bi unaprijedilo njihovo zdravlje i spriječilo nastanak bolesti u svezi s radom, ali i omogućilo bolju zaštitu već oboljelim medicinskim sestrama

Ramucirumab with cisplatin and fluoropyrimidine as first-line therapy in patients with metastatic gastric or junctional adenocarcinoma (RAINFALL): a double-blind, randomised, placebo-controlled, phase 3 trial

BACKGROUND: VEGF and VEGF receptor 2 (VEGFR-2)-mediated signalling and angiogenesis can contribute to the pathogenesis and progression of gastric cancer. We aimed to assess whether the addition of ramucirumab, a VEGFR-2 antagonist monoclonal antibody, to first-line chemotherapy improves outcomes in patients with metastatic gastric or gastro-oesophageal junction adenocarcinoma. METHODS: For this double-blind, randomised, placebo-controlled, phase 3 trial done at 126 centres in 20 countries, we recruited patients aged 18 years or older with metastatic, HER2-negative gastric or gastro-oesophageal junction adenocarcinoma, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate organ function. Eligible patients were randomly assigned (1:1) with an interactive web response system to receive cisplatin (80 mg/m2, on the first day) plus capecitabine (1000 mg/m2, twice daily for 14 days), every 21 days, and either ramucirumab (8 mg/kg) or placebo on days 1 and 8, every 21 days. 5-Fluorouracil (800 mg/m2 intravenous infusion on days 1-5) was permitted in patients unable to take capecitabine. The primary endpoint was investigator-assessed progression-free survival, analysed by intention to treat in the first 508 patients. We did a sensitivity analysis of the primary endpoint, including a central review of CT scans. Overall survival was a key secondary endpoint. This study is registered with ClinicalTrials.gov, number NCT02314117. FINDINGS: Between Jan 28, 2015, and Sept 16, 2016, 645 patients were randomly assigned to receive ramucirumab plus fluoropyrimidine and cisplatin (n=326) or placebo plus fluoropyrimidine and cisplatin (n=319). Investigator-assessed progression-free survival was significantly longer in the ramucirumab group than the placebo group (hazard ratio [HR] 0·753, 95% CI 0·607-0·935, p=0·0106; median progression-free survival 5·7 months [5·5-6·5] vs 5·4 months [4·5-5·7]). A sensitivity analysis based on central independent review of the radiological images did not corroborate the investigator-assessed difference in progression-free survival (HR 0·961, 95% CI 0·768-1·203, p=0·74). There was no difference in overall survival between groups (0·962, 0·801-1·156, p=0·6757; median overall survival 11·2 months [9·9-11·9] in the ramucirumab group vs 10·7 months [9·5-11·9] in the placebo group). The most common grade 3-4 adverse events were neutropenia (85 [26%] of 323 patients in the ramucirumab group vs 85 [27%] of 315 in the placebo group), anaemia (39 [12%] vs 44 [14%]), and hypertension (32 [10%] vs 5 [2%]). The incidence of any-grade serious adverse events was 160 (50%) of 323 patients in the ramucirumab group and 149 (47%) of 315 patients in the placebo group. The most common serious adverse events were vomiting (14 [4%] in the ramucirumab group vs 21 [7%] in the placebo group) and diarrhoea (11 [3%] vs 19 [6%]). There were seven deaths in each group, either during study treatment or within 30 days of discontinuing study treatment, which were the result of treatment-related adverse events. In the ramucirumab group, these adverse events were acute kidney injury, cardiac arrest, gastric haemorrhage, peritonitis, pneumothorax, septic shock, and sudden death (n=1 of each). In the placebo group, these adverse events were cerebrovascular accident (n=1), multiple organ dysfunction syndrome (n=2), pulmonary embolism (n=2), sepsis (n=1), and small intestine perforation (n=1). INTERPRETATION: Although the primary analysis for progression-free survival was statistically significant, this outcome was not confirmed in a sensitivity analysis of progression-free survival by central independent review, and did not improve overall survival. Therefore, the addition of ramucirumab to cisplatin plus fluoropyrimidine chemotherapy is not recommended as first-line treatment for this patient population. FUNDING: Eli Lilly and Company.status: publishe