Fall Chinook Salmon Spawning Ground Surveys in the Snake River Basin Upriver of Lower Granite Dam, 2004 Annual Report.

Redd counts were used to document the spawning distribution of fall Chinook salmon (Oncorhynchus tshawytscha) in the Snake River basin upriver of Lower Granite Dam. The first reported redd counts were from aerial searches conducted intermittently between 1959 and 1978 (Irving and Bjornn 1981, Witty 1988; Groves and Chandler 1996)(Appendix 1). In 1986, the Washington Department of Fish and Wildlife began an annual monitoring program that, in addition to the Snake River, included aerial searches of the Grande Ronde River the first year (Seidel and Bugert 1987), and the Imnaha River in subsequent years (Seidel et al. 1988; Bugert et al. 1989-1991; Mendel et al. 1992). The U.S. Fish and Wildlife Service and Idaho Power Company began contributing to this effort in 1991 by increasing the number of aerial searches conducted each year and adding underwater searches in areas of the Snake River that were too deep to be searched from the air (Connor et al. 1993; Garcia et al. 1994a, 1994b, 1996-2004; Groves 1993; Groves and Chandler 1996). The Nez Perce Tribe added aerial searches in the Clearwater River basin beginning in 1988 (Arnsberg et. al 1992), and the Salmon River beginning in 1992. Currently searches are conducted cooperatively by the Nez Perce Tribe, Idaho Power Company, and U. S. Fish and Wildlife Service. Our objective for this report was to consolidate the findings from annual redd searches into a single document, containing detailed information about the searches from the most recent spawning season, and summary information from previous years. The work conducted in 2004 was funded by the Bonneville Power Administration, Idaho Power Company, and Bureau of Land Management

Fall Chinook Salmon Spawning Ground Surveys in the Snake River Basin Upriver of Lower Granite Dam, 2005 Annual Report.

Redd counts are routinely used to document the spawning distribution of fall Chinook salmon (Oncorhynchus tshawytscha) in the Snake River basin upriver of Lower Granite Dam. The first reported redd counts were from aerial searches conducted intermittently between 1959 and 1978 (Irving and Bjornn 1981, Witty 1988; Groves and Chandler 1996)(Appendix 1). In 1986, the Washington Department of Fish and Wildlife began an annual monitoring program that, in addition to the Snake River, included aerial searches of the Grande Ronde River the first year (Seidel and Bugert 1987), and the Imnaha River in subsequent years (Seidel et al. 1988; Bugert et al. 1989-1991; Mendel et al. 1992). The U. S. Fish and Wildlife Service and Idaho Power Company began contributing to this effort in 1991 by increasing the number of aerial searches conducted each year and adding underwater searches in areas of the Snake River that were too deep to be searched from the air (Connor et al. 1993; Garcia et al. 1994a, 1994b, 1996-2005; Groves 1993; Groves and Chandler 1996). The Nez Perce Tribe added aerial searches in the Clearwater River basin beginning in 1988 (Arnsberg et. al 1992), and the Salmon River beginning in 1992. Currently searches are conducted cooperatively by the Nez Perce Tribe, Idaho Power Company, and U.S. Fish and Wildlife Service. Our objective for this report was to consolidate the findings from annual redd searches into a single document, containing detailed information about the searches from the most recent spawning season, and summary information from previous years. The work conducted in 2005 was funded by the Bonneville Power Administration and Idaho Power Company

Pragmatic considerations for negative control outcome studies to guide non-randomized comparative analyses: A narrative review

Purpose: This narrative review describes the application of negative control outcome (NCO) methods to assess potential bias due to unmeasured or mismeasured confounders in non-randomized comparisons of drug effectiveness and safety. An NCO is assumed to have no causal relationship with a treatment under study while subject to the same confounding structure as the treatment and outcome of interest; an association between treatment and NCO then reflects the potential for uncontrolled confounding between treatment and outcome. Methods: We focus on two recently completed NCO studies that assessed the comparability of outcome risk for patients initiating different osteoporosis medications and lipid-lowering therapies, illustrating several ways in which confounding may result. In these studies, NCO methods were implemented in claims-based data sources, with the results used to guide the decision to proceed with comparative effectiveness or safety analyses. Results: Based on this research, we provide recommendations for future NCO studies, including considerations for the identification of confounding mechanisms in the target patient population, the selection of NCOs expected to satisfy required assumptions, the interpretation of NCO effect estimates, and the mitigation of uncontrolled confounding detected in NCO analyses. We propose the use of NCO studies prior to initiating comparative effectiveness or safety research, providing information on the potential presence of uncontrolled confounding in those comparative analyses. Conclusions: Given the increasing use of non-randomized designs for regulatory decision-making, the application of NCO methods will strengthen study design, analysis, and interpretation of real-world data and the credibility of the resulting real-world evidence

Excess deaths attributable to influenza-like illness in the ESRD population

Background Morbidity and mortality vary seasonally. Timing and severity of influenza seasons contribute to those patterns, especially among vulnerable populations such as patients with ESRD. However, the extent to which influenza-like illness (ILI), a syndrome comprising a range of potentially serious respiratory tract infections, contributes to mortality in patients with ESRD has not been quantified. Methods We used data from the Centers for Disease Control and Prevention (CDC) Outpatient Influenzalike Illness Surveillance Network and Centers for Medicare and Medicaid Services ESRD death data from 2000 to 2013. After addressing the increasing trend in deaths due to the growing prevalent ESRD population, we calculated quarterly relative mortality compared with average third-quarter (summer) death counts. We used linear regression models to assess the relationship between ILI data and mortality, separately for quarters 4 and 1 for each influenza season, and model parameter estimates to predict seasonal mortality counts and calculate excess ILI-associated deaths. Results An estimated 1% absolute increase in quarterly ILI was associated with a 1.5% increase in relative mortality for quarter 4 and a 2.0% increase for quarter 1. The average number of annual deaths potentially attributable to ILI was substantial, about 1100 deaths per year. Conclusions We found an association between community ILI activity and seasonal variation in all-cause mortality in patients with ESRD, with ILI likely contributing to .1000 deaths annually. Surveillance efforts, such as timely reporting to the CDC of ILI activity within dialysis units during influenza season, may help focus attention on high-risk periods for this vulnerable population

Epoetin alfa and outcomes in dialysis amid regulatory and payment reform

Erythropoiesis-stimulating agents (ESAs) are commonly used to treat anemia in patients with CKD, including those receiving dialysis, although clinical trials have identified risks associated with ESA use. We evaluated the effects of changes in dialysis payment policies and product labeling instituted in 2011 on mortality and major cardiovascular events across the United States dialysis population in an open cohort study of patients on dialysis from January 1, 2005, through December 31, 2012, with Medicare as primary payer. We compared observed rates of death and major cardiovascular events in 2011 and 2012 with expected rates calculated on the basis of rates in 2005-2010, accounting for differences in patient characteristics and influenza virulence. An abrupt decline in erythropoietin dosing and hemoglobin concentration began in late 2010. Observed rates of all-cause mortality, cardiovascularmortality, andmyocardial infarction in 2011 and 2012 were consistent with expected rates. During 2012, observed rates of stroke, venous thromboembolic disease (VTE), and heart failure were lower than expected (absolute deviation from trend per 100 patient-years [95% confidence interval]: 20.24 [20.08 to 20.37] for stroke, 22.43 [21.35 to 23.70] for VTE, and 20.77 [20.28 to 21.27] for heart failure), although non-ESA-related changes in practice and Medicare payment penalties for rehospitalization may have confounded the results. This initial evidence suggests that action taken to mitigate risks associated with ESA use and changes in payment policy did not result in a relative increase in death or major cardiovascular events and may reflect improvements in stroke, VTE, and heart failure

Characteristics and outcomes of hospitalised adults with COVID-19 in a Global Health Research Network: A cohort study

Objective To examine age, gender, and temporal differences in baseline characteristics and clinical outcomes of adult patients hospitalised with COVID-19. Design A cohort study using deidentified electronic medical records from a Global Research Network. Setting/Participants 67 456 adult patients hospitalised with COVID-19 from the USA; 7306 from Europe, Latin America and Asia-Pacific between February 2020 and January 2021. Results In the US cohort, compared with patients 18-34 years old, patients ≥65 had a greater risk of intensive care unit (ICU) admission (adjusted HR (aHR) 1.73, 95% CI 1.58 to 1.90), acute respiratory distress syndrome(ARDS)/respiratory failure (aHR 1.86, 95% CI 1.76 to 1.96), invasive mechanical ventilation (IMV, aHR 1.93, 95% CI, 1.73 to 2.15), and all-cause mortality (aHR 5.6, 95% CI 4.36 to 7.18). Men appeared to be at a greater risk for ICU admission (aHR 1.34, 95% CI 1.29 to 1.39), ARDS/respiratory failure (aHR 1.24, 95% CI1.21 to 1.27), IMV (aHR 1.38, 95% CI 1.32 to 1.45), and all-cause mortality (aHR 1.16, 95% CI 1.08 to 1.24) compared with women. Moreover, we observed a greater risk of adverse outcomes during the early pandemic (ie, February-April 2020) compared with later periods. In the ex-US cohort, the age and gender trends were similar; for the temporal trend, the highest proportion of patients with all-cause mortality were also in February-April 2020; however, the highest percentages of patients with IMV and ARDS/respiratory failure were in August-October 2020 followed by February-April 2020. Conclusions This study provided valuable information on the temporal trends of characteristics and outcomes of hospitalised adult COVID-19 patients in both USA and ex-USA. It also described the population at a potentially greater risk for worse clinical outcomes by identifying the age and gender differences. Together, the information could inform the prevention and treatment strategies of COVID-19. Furthermore, it can be used to raise public awareness of COVID-19's impact on vulnerable populations

Trends in characteristics and outcomes among US adults hospitalised with COVID-19 throughout 2020: An observational cohort study

Objectives To examine the temporal patterns of patient characteristics, treatments used and outcomes associated with COVID-19 in patients who were hospitalised for the disease between January and 15 November 2020. Design Observational cohort study. Setting COVID-19 subset of the Optum deidentified electronic health records, including more than 1.8 million patients from across the USA. Participants There were 51 510 hospitalised patients who met the COVID-19 definition, with 37 617 in the laboratory positive cohort and 13 893 in the clinical cohort. Primary and secondary outcome measures Incident acute clinical outcomes, including in-hospital all-cause mortality. Results Respectively, 48% and 49% of the laboratory positive and clinical cohorts were women. The 50- 65 age group was the median age group for both cohorts. The use of antivirals and dexamethasone increased over time, fivefold and twofold, respectively, while the use of hydroxychloroquine declined by 98%. Among adult patients in the laboratory positive cohort, absolute age/sex standardised incidence proportion for in-hospital death changed by -0.036 per month (95% CI -0.042 to -0.031) from March to June 2020, but remained fairly flat from June to November, 2020 (0.001 (95% CI -0.001 to 0.003), 17.5% (660 deaths /3986 persons) in March and 10.2% (580/5137) in October); in the clinical cohort, the corresponding changes were -0.024 (95% CI -0.032 to -0.015) and 0.011 (95% CI 0.007 0.014), respectively (14.8% (175/1252) in March, 15.3% (189/1203) in October). Declines in the cumulative incidence of most acute clinical outcomes were observed in the laboratory positive cohort, but not for the clinical cohort. Conclusion The incidence of adverse clinical outcomes remains high among COVID-19 patients with clinical diagnosis only. Patients with COVID-19 entering the hospital are at elevated risk of adverse outcomes

Fall Chinook Salmon Spawning Ground Surveys in the Snake River Basin Upriver of Lower Granite Dam, 2007 Annual Report.

Redd counts are routinely used to document the spawning distribution of fall Chinook salmon (Oncorhynchus tshawytscha) in the Snake River basin upriver of Lower Granite Dam. The first reported redd counts were from aerial searches conducted intermittently between 1959 and 1978 (Irving and Bjornn 1981, Witty 1988; Groves and Chandler 1996)(Appendix 1). In 1986, the Washington Department of Fish and Wildlife began an annual monitoring program that, in addition to the Snake River, included aerial searches of the Grande Ronde River the first year (Seidel and Bugert 1987), and the Imnaha River in subsequent years (Seidel et al. 1988; Bugert et al. 1989-1991; Mendel et al. 1992). The U. S. Fish and Wildlife Service and Idaho Power Company began contributing to this effort in 1991 by increasing the number of aerial searches conducted each year and adding underwater searches in areas of the Snake River that were too deep to be searched from the air (Connor et al. 1993; Garcia et al. 1994a, 1994b, 1996-2007; Groves 1993; Groves and Chandler 1996). The Nez Perce Tribe added aerial searches in the Clearwater River basin beginning in 1988 (Arnsberg et. al 1992), and the Salmon River beginning in 1992. Currently searches are conducted cooperatively by the Nez Perce Tribe, Idaho Power Company, and U. S. Fish and Wildlife Service. Our objective for this report was to consolidate the findings from annual redd searches counted upstream of Lower Granite Dam into a single document, containing detailed information about the searches from the most recent spawning season, and summary information from previous years. The work conducted in 2007 was funded by the Bonneville Power Administration and Idaho Power Company

Using negative control outcomes to assess the comparability of treatment groups among women with osteoporosis in the United States

Purpose: In contrast to randomized clinical trials, comparative safety and effectiveness assessments of osteoporosis medications in clinical practice may be subject to confounding by indication. We used negative control outcomes to detect residual confounding when comparing osteoporosis medications. Methods: Using MarketScan Commercial and Supplemental claims, we identified women aged ≥55 years who initiated an oral bisphosphonate (BP) (risedronate, alendronate, or ibandronate), denosumab (an injected biologic), or intravenous zoledronic acid (ZA) from October 1, 2010 to September 30, 2015. Women with Paget's disease or cancer were excluded. We compared individual oral BPs to each other, denosumab to ZA, denosumab to oral BPs, and ZA to oral BPs, with respect to 11 negative control outcomes identified by subject matter experts. We estimated the 12-month cumulative risk difference (RD) using inverse probability of treatment and censoring weights. Results: Among 148 587 women, most initiated alendronate (57%), followed by ibandronate (12%), ZA (11%), risedronate (10%), and denosumab (10%). Compared with denosumab, patients initiating ZA had similar risks of all negative control outcomes. Compared with oral BPs, patients initiating denosumab had a higher risk of a wellness visit (RD = 1.2%, 95% CI: 0.4, 1.9) and a lower risk of receiving herpes zoster vaccine (RD = −0.6%, 95% CI: −1.1, −0.2). Comparing ZA with oral BP initiators resulted in two outcomes with positive associations. Conclusions: Caution is warranted when comparing injectable vs oral osteoporosis medications, given the potential for unmeasured confounding. Evaluating negative control outcomes could be a standard validity check prior to conducting comparative studies