Defining a research agenda for layperson prehospital hemorrhage control: A consensus statement

Importance: Trauma is the leading cause of death for US individuals younger than 45 years, and uncontrolled hemorrhage is a major cause of trauma mortality. The US military\u27s medical advancements in the field of prehospital hemorrhage control have reduced battlefield mortality by 44%. However, despite support from many national health care organizations, no integrated approach to research has been made regarding implementation, epidemiology, education, and logistics of prehospital hemorrhage control by layperson immediate responders in the civilian sector.Objective: To create a national research agenda to help guide future work for prehospital hemorrhage control by laypersons.Evidence review: The 2-day, in-person, National Stop the Bleed (STB) Research Consensus Conference was conducted on February 27 to 28, 2019, to identify and achieve consensus on research gaps. Participants included (1) subject matter experts, (2) professional society-designated leaders, (3) representatives from the federal government, and (4) representatives from private foundations. Before the conference, participants were provided a scoping review on layperson prehospital hemorrhage control. A 3-round modified Delphi consensus process was conducted to determine high-priority research questions. The top items, with median rating of 8 or more on a Likert scale of 1 to 9 points, were identified and became part of the national STB research agenda.Findings: Forty-five participants attended the conference. In round 1, participants submitted 487 research questions. After deduplication and sorting, 162 questions remained across 5 a priori-defined themes. Two subsequent rounds of rating generated consensus on 113 high-priority, 27 uncertain-priority, and 22 low-priority questions. The final prioritized research agenda included the top 24 questions, including 8 for epidemiology and effectiveness, 4 for materials, 9 for education, 2 for global health, and 1 for health policy.Conclusions and relevance: The National STB Research Consensus Conference identified and prioritized a national research agenda to support laypersons in reducing preventable deaths due to life-threatening hemorrhage. Investigators and funding agencies can use this agenda to guide their future work and funding priorities

ASSERT trial – How to assess the safety and efficacy of a high frequency rTMS in postpartum depression ? A multicenter, double blinded, randomized, placebo-controlled clinical trial

Background: Postpartum Depression affects a considerable number of women worldwide. This condition inflicts severe consequences to mother and child health. Thus far, available treatments have low response and high relapse rates. We designed this trial to evaluate a safe and more efficacious innovative therapy. Aims To report a feasible and ethical study design to assess the safety and efficacy of a high frequency repetitive Transcranial Magnetic Stimulation 10 Hz (rTMS) compared to sham rTMS in women with moderate to severe Post-Partum Depression using standard treatment (sertraline). To conduct an ancillary, exploratory, randomized, active controlled, double blind study with a hypothesis to assess the safety and efficacy of 10 Hz rTMS compared to sertraline. Methods: A multicenter, parallel arm, randomized, placebo-controlled, double-blind design to assess safety and efficacy of 10 Hz rTMS compared to sham. An ancillary study will be conducted with parallel arm, randomized, active controlled and double dummy design to assess safety and efficacy of 10 Hz rTMS compared to sertraline

The optimal length of stay associated with the lowest readmission risk following surgery

Background: Index length of stay (LOS) and readmissions are viewed as important quality measures. However, these metrics represent competing demands as an inordinate reduction in LOS may lead to unplanned readmissions. We sought to assess the optimal LOS associated with the lowest 90-d readmission rate following discharge after common surgical procedures. Materials and methods: This was a retrospective study relying on Tricare claims. We identified all eligible adult patients (18-64 y) receiving a series of common surgical procedures between 2006 and 2014. We used a generalized additive model with spline regression to determine the optimal LOS associated with the lowest 90-d risk of readmission. Results: Ninety-day readmission rates varied from 6.03% to 34.69%. Most procedures exhibited a logit linear relationship, with the lowest risk of readmission evident on postoperative day-1 and increasing thereafter. Among the more invasive procedures (e.g., esophagectomy and radical cystectomy), a U-shaped relationship was realized, indicating that expedited discharge would increase the potential for readmission as would any extended hospital LOS. For these procedures, the ideal index LOS appeared to be 6-7 d for radical cystectomy and 12-13 d for esophagectomy. Conclusions: Our results support the practice of discharging patients as soon as clinically feasible after hip and knee arthroplasty, lumbar spine surgery, hernia repair, appendectomy, nephrectomy, and colectomy. Among esophagectomy or radical cystectomy, there is a well-defined optimal index admission period and discharge outside this window appears to be detrimental. Our results suggest that invasive procedures appear to possess a unique signature when it comes to optimal LOS

Association of Medicaid expansion policy with outcomes in homeless patients requiring emergency general surgery

Background: Medicaid expansion has reduced obstacles faced in receiving care. Emergency general surgery (EGS) is a clinical event where delays in appropriate care impact outcomes. Therefore, we assessed the association between non-Medicaid expansion policy and multiple outcomes in homeless patients requiring EGS.Methods: We used 2014 State Inpatient Database to identify homeless individuals admitted with a primary EGS diagnosis who underwent an EGS procedure. States were divided into those that did and did not implement Medicaid expansion. Multivariable quantile regression was used to examine associations between non-Medicaid expansion states and (1) length of stay and (2) total index hospital charges within the homeless population. Multivariable logistic regression was used to assess the associations between non-Medicaid expansion and (1) mortality, (2) surgical complications, (3) discharge against medical advice, and (4) home healthcare.Results: A total of 6930 homeless patients were identified. Of these, 435 (6.2%) were in non-expansion states. Non-Medicaid expansion was associated with higher charges (coef: $46,264, 95% CI 40,388-52,139). There were non-significant differences in mortality (OR 1.4, 95% CI 0.79-2.62; p = 0.2) or surgical complications (OR 1.16, 95% CI 0.7-1.8; p = 0.4). However, homeless individuals living in non-expansion states did have higher odds of being discharged against medical advice (OR 2.1, 95% CI 1.08-4.05; p = 0.02), and lower odds of receiving home healthcare (OR 0.6, 95% CI 0.4-0.8; p = 0.01).Conclusion: Homeless patients living in Medicaid expansion states had lower odds of being discharged against medical advice, higher likelihood of receiving home healthcare and overall lower total index hospital charges

ASSERT trial - How to assess the safety and efficacy of a high frequency rTMS in postpartum depression ? A multicenter, double blinded, randomized, placebo-controlled clinical trial

Background: Postpartum Depression affects a considerable number of women worldwide. This condition inflicts severe consequences to mother and child health. Thus far, available treatments have low response and high relapse rates. We designed this trial to evaluate a safe and more efficacious innovative therapy. Aims: To report a feasible and ethical study design to assess the safety and efficacy of a high frequency repetitive Transcranial Magnetic Stimulation 10 Hz (rTMS) compared to sham rTMS in women with moderate to severe Post-Partum Depression using standard treatment (sertraline). To conduct an ancillary, exploratory, randomized, active controlled, double blind study with a hypothesis to assess the safety and efficacy of 10 Hz rTMS compared to sertraline

ASSERT trial – How to assess the safety and efficacy of a high frequency rTMS in postpartum depression ? A multicenter, double blinded, randomized, placebo-controlled clinical trial

Background: Postpartum Depression affects a considerable number of women worldwide. This condition inflicts severe consequences to mother and child health. Thus far, available treatments have low response and high relapse rates. We designed this trial to evaluate a safe and more efficacious innovative therapy. Aims: To report a feasible and ethical study design to assess the safety and efficacy of a high frequency repetitive Transcranial Magnetic Stimulation 10 Hz (rTMS) compared to sham rTMS in women with moderate to severe Post-Partum Depression using standard treatment (sertraline). To conduct an ancillary, exploratory, randomized, active controlled, double blind study with a hypothesis to assess the safety and efficacy of 10 Hz rTMS compared to sertraline. Methods: A multicenter, parallel arm, randomized, placebo-controlled, double-blind design to assess safety and efficacy of 10 Hz rTMS compared to sham. An ancillary study will be conducted with parallel arm, randomized, active controlled and double dummy design to assess safety and efficacy of 10 Hz rTMS compared to sertraline