Surgical Intensive Care Unit Optimal Mobilisation Score (SOMS) trial: a protocol for an international, multicentre, randomised controlled trial focused on goal-directed early mobilisation of surgical ICU patients

Introduction: Immobilisation in the intensive care unit (ICU) leads to muscle weakness and is associated with increased costs and long-term functional disability. Previous studies showed early mobilisation of medical ICU patients improves clinical outcomes. The Surgical ICU Optimal Mobilisation Score (SOMS) trial aims to test whether a budget-neutral intervention to facilitate goal-directed early mobilisation in the surgical ICU improves participant mobilisation and associated clinical outcomes. Methods and analysis The SOMS trial is an international, multicentre, randomised clinical study being conducted in the USA and Europe. We are targeting 200 patients. The primary outcome is average daily SOMS level and key secondary outcomes are ICU length of stay until discharge readiness and ‘mini’ modified Functional Independence Measure (mmFIM) at hospital discharge. Additional secondary outcomes include quality of life assessed at 3 months after hospital discharge and global muscle strength at ICU discharge. Exploratory outcomes will include: ventilator-free days, ICU and hospital length of stay and 3-month mortality. We will explore genetic influences on the effectiveness of early mobilisation and centre-specific effects of early mobilisation on outcomes. Ethics and dissemination Following Institutional Review Board (IRB) approval in three institutions, we started study recruitment and plan to expand to additional centres in Germany and Italy. Safety monitoring will be the domain of the Data and Safety Monitoring Board (DSMB). The SOMS trial will also explore the feasibility of a transcontinental study on early mobilisation in the surgical ICU. Results: The results of this study, along with those of ancillary studies, will be made available in the form of manuscripts and presentations at national and international meetings. Registration This study has been registered at clinicaltrials.gov (NCT01363102)

Association of tumor necrosis factor-alpha-238G\u3eA and apolipoprotein E2 polymorphisms with intracranial hemorrhage after brain arteriovenous malformation treatment

OBJECTIVE: We previously reported specific genotypes of polymorphisms in two genes, tumor necrosis factor-alpha (TNF-alpha-238G \u3e A) and Apolipoprotein E (ApoE e2), as independent predictors of new intracranial hemorrhage (ICH) in the natural course of untreated brain arteriovenous malformations. We hypothesized that the risk of posttreatment ICH would also be greater in patients with brain arteriovenous malformations with these genotypes. METHODS: Two hundred fifteen patients undergoing brain arteriovenous malformation treatment (embolization, arteriovenous malformation resection, radiosurgery, or any combination of these) were genotyped and followed longitudinally. Association of genotype with new symptomatic ICH after initiation of treatment was assessed using Cox proportional hazards adjusted for treatment type, demographics, and established ICH risk factors censored at the time of the last follow-up evaluation or death. RESULTS: The cohort was 48% male and 55% Caucasian, and 52% had an ICH before the initiation of treatment; the mean age +/- standard deviation was 36.6 +/- 17.2 years. Posttreatment ICH occurred in 34 (16%) patients with a median follow-up period of 1.9 years (interquartile range, 1.6 yr). After adjustment, the risk of posttreatment ICH was greater for TNF-alpha-238 AG genotype (hazard ratio [HR], 3.5; 95% confidence interval [CI], 1.3-9.8; P = 0.016) and ApoE e2 (HR, 3.2; 95% CI, 1.0-9.7; P = 0.042). Similar trends for the TNF-alpha-238 AG genotype were seen in surgery (HR, 4.2; 95% CI, 0.6-28.8; P = 0.14) and radiosurgery subsets (HR, 3.8; 95% CI, 0.7-19.4; P = 0.11). An effect of ApoE e2 was seen in radiosurgery subsets (HR, 10.9; 95% CI, 1.3-93.7; P = 0.030), but not in surgery subsets (HR, 1.4; 95% CI, 0.3-7.4; P = 0.67). CONCLUSION: Despite a variety of different mechanisms for posttreatment hemorrhage, these data suggest that the TNF-alpha and ApoE genotypes may contribute common phenotypes of enhanced vascular instability that increase the risk of hemorrhagic outcome

Qualitative factors in patients who die shortly after emergency department discharge.

ObjectivesEarly death after emergency department (ED) discharge may signal opportunities to improve care. Prior studies are limited by incomplete mortality ascertainment and lack of clinically important information in administrative data. The goal in this hypothesis-generating study was to identify patient and process of care themes that may provide possible explanations for early postdischarge mortality.MethodsThis was a qualitative analysis of medical records of adult patients who visited the ED of any of six hospitals in an integrated health system (Kaiser Permanente Southern California [KPSC]) and died within 7 days of discharge in 2007 and 2008. Nonmembers, visits to non-health plan hospitals, patients receiving or referred to hospice care, and patients with do not attempt resuscitation or do not intubate orders (DNAR/DNI) were excluded. Under the guidance of two qualitative research scientists, a team of three emergency physicians used grounded theory techniques to identify patient clinical presentations and processes of care that serve as potential explanations for poor outcome after discharge.ResultsThe source population consisted of a total of 290,092 members with 446,120 discharges from six KPSC EDs in 2007 and 2008. A total of 203 deaths occurred within 7 days of ED discharge (0.05%). Sixty-one randomly chosen cases were reviewed. Patient-level themes that emerged included an unexplained persistent acute change in mental status, recent fall, abnormal vital signs, ill-appearing presentation, malfunctioning indwelling device, and presenting symptoms remaining at discharge. Process-of-care factors included a discrepancy in history of present illness, incomplete physical examination, and change of discharge plan by a third party, such as a consulting or admitting physician.ConclusionsIn this hypothesis-generating study, qualitative research techniques were used to identify clinical and process-of-care factors in patients who died within days after discharge from an ED. These potential predictors will be formally tested in a future quantitative study