Text-based vs. graphical information formats in sepsis prevention and early detection: A randomized controlled trial on informed choice

Sepsis is associated with 11 million global deaths annually. Although serious consequences of sepsis can generally be avoided with prevention and early detection, research has not yet addressed the efficacy of evidence-based health information formats for different risk groups. This study examines whether two evidence-based health information formats—text based and graphical—differ in how well they foster informed choice and risk and health literacy and in how well they support different sepsis risk groups. Based on a systematic literature review, two one-page educative formats on sepsis prevention and early detection were designed—one text based and one graphical. A sample of 500 German participants was randomly shown one of the two formats; they were then assessed on whether they made informed choices and on their risk and health literacy. For both formats, >70% of participants made informed choices for sepsis prevention and >75% for early detection. Compared with the graphical format, the text-based format was associated with higher degrees of informed choice (p = 0.012, OR = 1.818) and risk and health literacy (p = 0.032, OR = 1.710). Both formats can foster informed choices and risk and health literacy on sepsis prevention and early detection, but the text-based format appears to be more effective

The effect of peri‐operative dexmedetomidine on the incidence of postoperative delirium in cardiac and non‐cardiac surgical patients: a randomised, double‐blind placebo‐controlled trial

Delirium occurs commonly following major non-cardiac and cardiac surgery and is associated with: postoperative mortality; postoperative neurocognitive dysfunction; increased length of hospital stay; and major postoperative complications and morbidity. The aim of this study was to investigate the effect of peri-operative administration of dexmedetomidine on the incidence of postoperative delirium in non-cardiac and cardiac surgical patients. In this randomised, double-blind placebo-controlled trial we included 63 patients aged >= 60 years undergoing major open abdominal surgery or coronary artery bypass graft surgery with cardiopulmonary bypass. The primary outcome was the incidence of postoperative delirium, as screened for with the Confusion Assessment Method. Delirium assessment was performed twice daily until postoperative day 5, at the time of discharge from hospital or until postoperative day 14. We found that dexmedetomidine was associated with a reduced incidence of postoperative delirium within the first 5 postoperative days, 43.8% vs. 17.9%, p = 0.038. Severity of delirium, screened with the Intensive Care Delirium Screening Checklist, was comparable in both groups, with a mean maximum score of 1.54 vs. 1.68, p = 0.767. No patients in the dexmedetomidine group died while five (15.6%) patients in the placebo group died, p = 0.029. For patients aged >= 60 years undergoing major cardiac or non-cardiac surgery, we conclude that the peri-operative administration of dexmedetomidine is associated with a lower incidence of postoperative delirium

Effectiveness of Lumbar Cerebrospinal Fluid Drain Among Patients With Aneurysmal Subarachnoid Hemorrhage: A Randomized Clinical Trial.

IMPORTANCE After aneurysmal subarachnoid hemorrhage, the use of lumbar drains has been suggested to decrease the incidence of delayed cerebral ischemia and improve long-term outcome. OBJECTIVE To determine the effectiveness of early lumbar cerebrospinal fluid drainage added to standard of care in patients after aneurysmal subarachnoid hemorrhage. DESIGN, SETTING, AND PARTICIPANTS The EARLYDRAIN trial was a pragmatic, multicenter, parallel-group, open-label randomized clinical trial with blinded end point evaluation conducted at 19 centers in Germany, Switzerland, and Canada. The first patient entered January 31, 2011, and the last on January 24, 2016, after 307 randomizations. Follow-up was completed July 2016. Query and retrieval of data on missing items in the case report forms was completed in September 2020. A total of 20 randomizations were invalid, the main reason being lack of informed consent. No participants meeting all inclusion and exclusion criteria were excluded from the intention-to-treat analysis. Exclusion of patients was only performed in per-protocol sensitivity analysis. A total of 287 adult patients with acute aneurysmal subarachnoid hemorrhage of all clinical grades were analyzable. Aneurysm treatment with clipping or coiling was performed within 48 hours. INTERVENTION A total of 144 patients were randomized to receive an additional lumbar drain after aneurysm treatment and 143 patients to standard of care only. Early lumbar drainage with 5 mL per hour was started within 72 hours of the subarachnoid hemorrhage. MAIN OUTCOMES AND MEASURES Primary outcome was the rate of unfavorable outcome, defined as modified Rankin Scale score of 3 to 6 (range, 0 to 6), obtained by masked assessors 6 months after hemorrhage. RESULTS Of 287 included patients, 197 (68.6%) were female, and the median (IQR) age was 55 (48-63) years. Lumbar drainage started at a median (IQR) of day 2 (1-2) after aneurysmal subarachnoid hemorrhage. At 6 months, 47 patients (32.6%) in the lumbar drain group and 64 patients (44.8%) in the standard of care group had an unfavorable neurological outcome (risk ratio, 0.73; 95% CI, 0.52 to 0.98; absolute risk difference, -0.12; 95% CI, -0.23 to -0.01; P = .04). Patients treated with a lumbar drain had fewer secondary infarctions at discharge (41 patients [28.5%] vs 57 patients [39.9%]; risk ratio, 0.71; 95% CI, 0.49 to 0.99; absolute risk difference, -0.11; 95% CI, -0.22 to 0; P = .04). CONCLUSION AND RELEVANCE In this trial, prophylactic lumbar drainage after aneurysmal subarachnoid hemorrhage lessened the burden of secondary infarction and decreased the rate of unfavorable outcome at 6 months. These findings support the use of lumbar drains after aneurysmal subarachnoid hemorrhage. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01258257

Effect of text-based vs. graphical information formats on informed choice in sepsis prevention and early detection: a randomized controlled trial

Sepsis is associated with 11 million global deaths annually. Although serious consequences of sepsis can generally be avoided with prevention and early detection, research has not yet addressed the efficacy of evidence-based health information formats for different risk groups. This study examines whether two evidence-based health information formats—text based and graphical—differ in how well they foster informed choice and risk and health literacy and in how well they support different sepsis risk groups. Based on a systematic literature review, two one-page educative formats on sepsis prevention and early detection were designed—one text based and one graphical. A sample of 500 German participants was randomly shown one of the two formats; they were then assessed on whether they made informed choices and on their risk and health literacy. For both formats, >70% of participants made informed choices for sepsis prevention and >75% for early detection. Compared with the graphical format, the text-based format was associated with higher degrees of informed choice (p = 0.012, OR = 1.818) and risk and health literacy (p = 0.032, OR = 1.710). Both formats can foster informed choices and risk and health literacy on sepsis prevention and early detection, but the text-based format appears to be more effective

Long-term effects of a food pattern on cardiovascular risk factors and age-related changes of muscular and cognitive function.

Introduction: The mean age of the German population increased over the last years, which resulted in a higher prevalence of cardiovascular diseases, type 2 diabetes, cognitive impairment, sarcopenia and bone fractures. Current evidence indicates a preservation of human wellbeing in the elderly by a healthy diet, although the recommended macronutrient composition and quality remains unclear and needs further long-term investigation. In this context we investigate the effect of a specific dietary pattern on age-related disorders in a randomized controlled multi-center trial (RCT). Methods: We assess the effect of a specific dietary pattern (NutriAct) with a high proportion of unsaturated fat, plant proteins and fibres (fat 35%-40% of total energy (%E) of which 15%E-20%E monounsaturated fatty acids (MUFA) and 10%E-15%E polyunsaturated fatty acids (PUFA), 15%E-25%E proteins, >= 30 g fibres per day and 35%E-45%E carbohydrates) on age-related impairment of health within a 36-months RCT conducted in the region of Berlin and Potsdam. 502 eligible men (n = 183) and women (n = 319), aged 50 to 80 years, with an increased risk to develop age-related diseases were randomly assigned to either an intervention group focusing on NutriAct dietary pattern or a control group focusing on usual care and dietary recommendations in accordance to the German Nutrition Society (DGE). In the intervention group, 21 nutrition counsellings as well as supplementation of rapeseed oil, oil cake and specific designed foods are used to achieve the intended NutriAct dietary pattern. The primary outcome is a composite endpoint of age-related disorders, including cardiovascular morbidity, decline of cognitive function as well as clinical features of sarcopenia. Secondary outcomes include diet-induced effects on quality of life, depression, frailty, cardiovascular function, bone density, fat distribution pattern, glucose, lipid and energy metabolism, as well as the identification of biomarkers linked with age-related disorders. Discussion: The findings of this trial will provide clinically relevant information regarding dietary effects on age-related impairment of health and will contribute to the definition of the optimal macronutrient composition in the context of healthy aging in the German population