Identification of Outer Continental Shelf Renewable Energy Space-Use Conflicts and Analysis of Potential Mitigation Measures

The ocean accommodates a wide variety of uses that are separated by time of day, season, location, and zones. Conflict can and does occur, however, when two or more groups wish to use the same space at the same time in an exclusive manner. The potential for conflict is well known and the management of ocean space and resources has been, and is being, addressed by a number of State, regional, and Federal organizations, including, among others, coastal zone management agencies, state task forces, and regional fisheries management councils. However, with new and emerging uses of the ocean, such as aquaculture and offshore renewable energy, comes the potential for new types of space-use conflicts in ocean waters. In recent years, the Bureau of Ocean Energy Management (BOEM) (formerly the Minerals Management Service [MMS]) has examined ocean space-use conflicts and mitigation strategies in the context of offshore oil and gas exploration and production and sand and gravel dredging, activities that are both subject to BOEM regulation and oversight. BOEM now has authority to issue leases on the Outer Continental Shelf (OCS) for renewable energy projects, but seeks additional information on potential conflicts between existing uses of the ocean environment and this new form of activity. The broad purpose of this study was to begin to fill this gap by (1) identifying potential spaceuse conflicts between OCS renewable energy development and other uses of the ocean environment, and (2) recommending measures that BOEM can implement in order to promote avoidance or mitigation of such conflicts, thereby facilitating responsible and efficient development of OCS renewable energy resources. The result is a document intended to serve as a desktop resource that BOEM can use to inform its decision making as the agency carries out its statutory and regulatory responsibilities

Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial.

Importance: Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited. Objective: To determine whether hydrocortisone improves outcome for patients with severe COVID-19. Design, Setting, and Participants: An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020. Interventions: The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108). Main Outcomes and Measures: The primary end point was organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned -1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%). Results: After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n = 137), shock-dependent (n = 146), and no (n = 101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis. The mean age for the 3 groups ranged between 59.5 and 60.4 years; most patients were male (range, 70.6%-71.5%); mean body mass index ranged between 29.7 and 30.9; and patients receiving mechanical ventilation ranged between 50.0% and 63.5%. For the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively, the median organ support-free days were 0 (IQR, -1 to 15), 0 (IQR, -1 to 13), and 0 (-1 to 11) days (composed of 30%, 26%, and 33% mortality rates and 11.5, 9.5, and 6 median organ support-free days among survivors). The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone. Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1%) patients in the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively. Conclusions and Relevance: Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support-free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions. Trial Registration: ClinicalTrials.gov Identifier: NCT02735707

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Integrating collaborative data collection with management: A lobster fishery test case

Cost-effective programs for gathering essential fisheries information (EFI) are critically needed toimprove the data-poor state of fisheries in California and worldwide. The California Marine LifeManagement Act (MLMA) recognizes this need and requires development of fishery managementplans (FMPs) that identify suitable protocols for collecting data, and use of the best availablescientific information to inform management. Furthermore, in the United States, several stateand federal laws require the engagement of fishermen and others in fisheries management. Toaddress these needs, we developed a collaborative at-sea sampling program (CASP) by:• determining the key regulatory, administrative and operational features of establishedcollaborative fisheries data collection programs,• developing a robust sampling design with associated protocols for the commercialCalifornia spiny lobster fishery,• designing, testing and modifying data collection and management components of thesampling program, and• exploring options for sustaining the program into the future.The goal of the program was to provide a model for generating an ongoing stream of diverse dataand interpretation for integration into management, thereby supporting use of moresophisticated and robust models for managing California fisheries.We used the California commercial fishery for spiny lobster, for which an FMP is being developed,as a test case. This project built upon earlier work by the co-PIs developing a CASP for California’ssouthern rock crab commercial fishery (Culver et al. 2010) and by Neilson to implement a lobsterfishery data collection program similar to one used in the New Zealand rock lobster fishery

Integrating collaborative data collection with management: A lobster fishery test case

Cost-effective programs for gathering essential fisheries information (EFI) are critically needed toimprove the data-poor state of fisheries in California and worldwide. The California Marine LifeManagement Act (MLMA) recognizes this need and requires development of fishery managementplans (FMPs) that identify suitable protocols for collecting data, and use of the best availablescientific information to inform management. Furthermore, in the United States, several stateand federal laws require the engagement of fishermen and others in fisheries management. Toaddress these needs, we developed a collaborative at-sea sampling program (CASP) by:• determining the key regulatory, administrative and operational features of establishedcollaborative fisheries data collection programs,• developing a robust sampling design with associated protocols for the commercialCalifornia spiny lobster fishery,• designing, testing and modifying data collection and management components of thesampling program, and• exploring options for sustaining the program into the future.The goal of the program was to provide a model for generating an ongoing stream of diverse dataand interpretation for integration into management, thereby supporting use of moresophisticated and robust models for managing California fisheries.We used the California commercial fishery for spiny lobster, for which an FMP is being developed,as a test case. This project built upon earlier work by the co-PIs developing a CASP for California’ssouthern rock crab commercial fishery (Culver et al. 2010) and by Neilson to implement a lobsterfishery data collection program similar to one used in the New Zealand rock lobster fishery

North Coast Seafood

Commercial fisheries are an important part of California's economy. In 2011, approximately $201 million dollars in ex-vessel revenue (the amount paid directly to fishermen) came from commercial fishery landings, and more than 120,000 jobs on and off the water were supported by the state's seafood industry (NOAA 2011). Fishing communities from Crescent City to San Diego are the centers of this activity, providing a diverse supply of seafood and a visual reminder of California's maritime heritage

South Coast Seafood

Commercial fisheries are an important part of California's economy. In 2011, approximately $201 million dollars in ex-vessel revenue (the amount paid directly to fishermen) came from commercial fishery landings, and more than 120,000 jobs on and off the water were supported by the state's seafood industry (NOAA 2011). Fishing communities from Crescent City to San Diego are the centers of this activity, providing a diverse supply of seafood and a visual reminder of California's maritime heritage

Santa Barbara Channel Seafood

Commercial fisheries are an important part of California's economy. In 2011, approximately $201 million dollars in ex-vessel revenue (the amount paid directly to fishermen) came from commercial fishery landings, and more than 120,000 jobs on and off the water were supported by the state's seafood industry (NOAA 2011). Fishing communities from Crescent City to San Diego are the centers of this activity, providing a diverse supply of seafood and a visual reminder of California's maritime heritage