What is the effectiveness and safety of mirtazapine versus escitalopram in alleviating cancer-associated poly-symptomatology (the MIR-P study)? A mixed-method randomized controlled trial protocol.

BACKGROUND: Advanced cancer patients often experience multiple symptoms at a same time. This might lead to polypharmacy and increase adverse events representing major threats to the quality of health care, especially in palliative care situations. Mirtazapine, an antidepressant agent, has been suggested as a potential relevant drug to alleviate multiple cancer-related symptoms at a same time. Therefore, the present study aims to assess the effectiveness of mirtazapine in alleviating multiple symptoms at a same time in advanced cancer patients suffering from a major depressive episode compared to a group receiving escitalopram, another antidepressant agent. METHODS: Multicentre, prospective, randomized, controlled trial in 12 palliative care services in France. The study will be based on a mixed-method methodology using parallel groups, of oral mirtazapine compared with oral escitalopram, with a 56 day follow-up. The primary outcome will be an improvement of the Global health Status (issued from the EORTC-QLQ-C30) on day 56. 418 participants will be clinically followed-up on day 7 and 56 and will have a telephonic assessment on days 14 and 28. A sub-sample of participants will be invited to take part in semi-structured qualitative interviews at baseline and day 56. For the qualitative part, purposeful sampling will be used. DISCUSSION: This study will provide evidence for the pharmaceutics management of poly-symptomatology in advanced cancer patients. This could lead to important changes in the management of those patients by using a single molecule to alleviate multiple symptoms at a same time, potentially improving medication adherence, symptoms' control, and reducing the risk of medications adverse events. TRIAL REGISTRATION: Trial registration: NCT04763135 . Registered 18 March 2021.

Impact of a Geriatric Intervention to Improve Screening and Management of Undernutrition in Older Patients Undergoing Surgery for Colorectal Cancer: Results of the ANC Stepped-Wedge Trial.

Almost two in three patients who are aged 75 years and older and scheduled for surgery for colorectal cancer (CRC) are undernourished. Despite evidence that perioperative nutritional management can improve patients outcomes, international guidelines are still insufficiently applied in current practice. In this stepped-wedge cluster-randomized study of five surgical hospitals, we included 147 patients aged 70 years or older with scheduled abdominal surgery for CRC between October 2013 and December 2016. In the intervention condition, an outreach team comprising a geriatrician and a dietician visited patients and staff in surgical wards to assist with the correct application of guidelines. Evaluation, diagnosis, and prescription (according to nutritional status) were considered appropriate and strictly consistent with guidelines in 39.2% of patients in the intervention group compared to only 1.4% in the control group (p = 0.0002). Prescription of oral nutritional supplements during the perioperative period was significantly improved (41.9% vs. 4.1%; p < 0.0001). However, there were no benefits of the intervention on surgical complications or adverse events. A possible benefit of hospital stay reduction will need to be confirmed in further studies. This study highlights the importance of the implementation of quality improvement interventions into current practice for the perioperative nutritional management of older patients with CRC.

Epidemiology of severe sepsis in the emergency department and difficulties in the initial assistance.

BACKGROUND: The aim of this study was to determine the occurrence rate, demographics, clinical characteristics, and outcomes of patients with severe sepsis admitted to the emergency department. METHODS: A prospective study evaluating all patients admitted to the emergency department unit in a public hospital of tertiary complexity in a six-month period was conducted. During this period, the emergency team was trained to diagnose sepsis. Patients who met the diagnostic criteria for severe sepsis were followed until their discharge from the hospital. RESULTS: A total of 5,332 patients were admitted to the emergency department, and 342 met the criteria for severe sepsis/septic shock. The median (interquartile range) age of patients was 74 (65-84) years, and 52.1% were male. The median APACHE II and SOFA scores at diagnosis were 19 (15-25) and 5 (3-7), respectively. The median number of dysfunctional organ systems per patient was 2 (1-3). The median hospital length of stay was 10 (4.7-17) days, and the hospital mortality rate was 64%. Only 31% of the patients were diagnosed by the emergency department team as septic. About 33.5% of the 342 severe sepsis patients admitted to the emergency department were referred to an ICU, with a median time delay of 24 (12-48) hours. Training improved diagnosis and decreased the time delay for septic patients in arriving at the ICU. CONCLUSIONS: The occurrence rate of severe sepsis in the emergency department was 6.4%, and the rate of sepsis diagnosed by the emergency department team as well as the number of patients transferred to the ICU was very low. Educational campaigns are important to improve diagnosis and, hence, treatment of severe sepsis.

Epidemiology of severe sepsis in the emergency department and difficulties in the initial assistance

BACKGROUND: The aim of this study was to determine the occurrence rate, demographics, clinical characteristics, and outcomes of patients with severe sepsis admitted to the emergency department. METHODS: A prospective study evaluating all patients admitted to the emergency department unit in a public hospital of tertiary complexity in a six-month period was conducted. During this period, the emergency team was trained to diagnose sepsis. Patients who met the diagnostic criteria for severe sepsis were followed until their discharge from the hospital. RESULTS: A total of 5,332 patients were admitted to the emergency department, and 342 met the criteria for severe sepsis/septic shock. The median (interquartile range) age of patients was 74 (65-84) years, and 52.1 percent were male. The median APACHE II and SOFA scores at diagnosis were 19 (15-25) and 5 (3-7), respectively. The median number of dysfunctional organ systems per patient was 2 (1-3). The median hospital length of stay was 10 (4.7-17) days, and the hospital mortality rate was 64 percent. Only 31 percent of the patients were diagnosed by the emergency department team as septic. About 33.5 percent of the 342 severe sepsis patients admitted to the emergency department were referred to an ICU, with a median time delay of 24 (12-48) hours. Training improved diagnosis and decreased the time delay for septic patients in arriving at the ICU. CONCLUSIONS: The occurrence rate of severe sepsis in the emergency department was 6.4 percent, and the rate of sepsis diagnosed by the emergency department team as well as the number of patients transferred to the ICU was very low. Educational campaigns are important to improve diagnosis and, hence, treatment of severe sepsis.