The impacts of mangrove range expansion on wetland ecosystem services in the southeastern United States: Current understanding, knowledge gaps, and emerging research needs.

Climate change is transforming ecosystems and affecting ecosystem goods and services. Along the Gulf of Mexico and Atlantic coasts of the southeastern United States, the frequency and intensity of extreme freeze events greatly influence whether coastal wetlands are dominated by freeze-sensitive woody plants (mangrove forests) or freeze-tolerant grass-like plants (salt marshes). In response to warming winters, mangroves have been expanding and displacing salt marshes at varying degrees of severity in parts of north Florida, Louisiana, and Texas. As winter warming accelerates, mangrove range expansion is expected to increasingly modify wetland ecosystem structure and function. Because there are differences in the ecological and societal benefits that salt marshes and mangroves provide, coastal environmental managers are challenged to anticipate the effects of mangrove expansion on critical wetland ecosystem services, including those related to carbon sequestration, wildlife habitat, storm protection, erosion reduction, water purification, fisheries support, and recreation. Mangrove range expansion may also affect wetland stability in the face of extreme climatic events and rising sea levels. Here, we review the current understanding of the effects of mangrove range expansion and displacement of salt marshes on wetland ecosystem services in the southeastern United States. We also identify critical knowledge gaps and emerging research needs regarding the ecological and societal implications of salt marsh displacement by expanding mangrove forests. One consistent theme throughout our review is that there are ecological trade-offs for consideration by coastal managers. Mangrove expansion and marsh displacement can produce beneficial changes in some ecosystem services, while simultaneously producing detrimental changes in other services. Thus, there can be local-scale differences in perceptions of the impacts of mangrove expansion into salt marshes. For very specific local reasons, some individuals may see mangrove expansion as a positive change to be embraced, while others may see mangrove expansion as a negative change to be constrained.

Electronic Cigarette Refill Liquids: Nicotine Content, Presence of Child-Resistant Packaging, and in-Shop Compounding.

PURPOSE: To expand on our 2015 study of the nicotine content accuracy of e-liquids, including salts, and the presence of child-resistant packaging. We also describe compounding in shop (CIS). DESIGN AND METHODS: We analyzed samples from 35 shops. CIS processing was observed. Descriptive statistics summarized the data, and inference was performed. RESULTS: Actual nicotine content was significantly less than the identified content, on average, with a mean percent deviation 34.0% below the identified content. Only 3.8% of the samples' actual nicotine content was within 10% of the identified content; the maximum deviation was 213.2%. Of eight uniquely packaged samples, including designs resembling pop cans, ice cream cones, etc., the mean percent deviation was -39.6%; none were within 10% of the identified content. Eight shops compounded samples. After removing outlier values, significant differences were found in the percent deviations between the CIS and non-CIS free-base samples. A significantly higher percentage of CIS samples had nicotine content > 10% above the identified content, and none were within 10%. One shop visually estimated the nicotine quantities to add, e-liquids were not always relabeled to reflect new nicotine levels, and protective materials were not always worn during compounding. Child-resistant packaging was not present for one third of the samples. CONCLUSIONS: Labeling of nicotine content in e-liquids remains inaccurate, child-resistant packaging is inconsistent, and CIS is problematic. Effective e-liquid regulation is needed to protect public health. PRACTICE IMPLICATIONS: Nurses should educate families about the serious health risks of e-liquids and advocate for increased e-liquid regulations.

Compliance with North Dakota's smoke-free law among vape and tobacco specialty shops.

OBJECTIVE: To determine compliance with North Dakota's smoke-free law in vape shops and other tobacco specialty shops selling electronic nicotine delivery systems (ENDS) or e-liquids. DESIGN: In this 2019 descriptive study, shops (n = 35) were assessed for compliance with the smoke-free law by observation of indoor and outdoor areas for smoking or vaping, or evidence of such activity in prohibited areas, and the presence of required no-smoking signs. RESULTS: Only two shops (5.7%) were fully compliant with the smoke-free law. Full compliance for indoor and outdoor environments was 8.5% and 42.8%, respectively. Vaping occurred inside five shops (14.3%), and smoking occurred outdoors within required smoke-free areas in two (5.7%) shops. Four (11.4%) and 17 (48.6%) shops complied with indoor and outdoor signage requirements, respectively. CONCLUSIONS: Overall compliance remained low, although much of the noncompliance was related to signage. Use or evidence of ENDS use occurred both indoors and outdoors where prohibited by law. Classifying ENDS as tobacco products would require tobacco licensure of shops selling ENDS and e-liquids, aiding in identification of the shops for education and enforcement efforts to ensure compliance with the law and to improve public health protection.

Systems Perspective for Incivility in Academia: An Integrative Review.

AIM: The purpose of this integrative review was to identify evidence of systems thinking on civility in academic settings. BACKGROUND: Incivility is present in academic systems, including nursing education. What is learned in academia translates to the workplace. Systems-based solutions may promote quality and safety in health care. METHOD: Whittemore and Knafl's integrative approach guided this study. RESULTS: Forty-nine articles were reviewed. Themes emerged describing incivility in nursing as embedded within layers of a performance-driven, oppressive hostile bureaucracy, trickling down, instilling fear, and reinforcing uncivil behavior among and between members. Other themes defined faculty-to-faculty and faculty-to-student incivilities, reasons for it, reactions to it, and suggestions for improved civility. CONCLUSION: The systems awareness model is offered as a means of promoting civility in nursing education. A lack of evidence to support how incivility in academia transfers to quality and safety in practice settings is identified as a gap for future study.

Long-term comparison of endovascular and open repair of abdominal aortic aneurysm.

BACKGROUND: Whether elective endovascular repair of abdominal aortic aneurysm reduces long-term morbidity and mortality, as compared with traditional open repair, remains uncertain. METHODS: We randomly assigned 881 patients with asymptomatic abdominal aortic aneurysms who were candidates for both procedures to either endovascular repair (444) or open repair (437) and followed them for up to 9 years (mean, 5.2). Patients were selected from 42 Veterans Affairs medical centers and were 49 years of age or older at the time of registration. RESULTS: More than 95% of the patients underwent the assigned repair. For the primary outcome of all-cause mortality, 146 deaths occurred in each group (hazard ratio with endovascular repair versus open repair, 0.97; 95% confidence interval [CI], 0.77 to 1.22; P=0.81). The previously reported reduction in perioperative mortality with endovascular repair was sustained at 2 years (hazard ratio, 0.63; 95% CI, 0.40 to 0.98; P=0.04) and at 3 years (hazard ratio, 0.72; 95% CI, 0.51 to 1.00; P=0.05) but not thereafter. There were 10 aneurysm-related deaths in the endovascular-repair group (2.3%) versus 16 in the open-repair group (3.7%) (P=0.22). Six aneurysm ruptures were confirmed in the endovascular-repair group versus none in the open-repair group (P=0.03). A significant interaction was observed between age and type of treatment (P=0.006); survival was increased among patients under 70 years of age in the endovascular-repair group but tended to be better among those 70 years of age or older in the open-repair group. CONCLUSIONS: Endovascular repair and open repair resulted in similar long-term survival. The perioperative survival advantage with endovascular repair was sustained for several years, but rupture after repair remained a concern. Endovascular repair led to increased long-term survival among younger patients but not among older patients, for whom a greater benefit from the endovascular approach had been expected. (Funded by the Department of Veterans Affairs Office of Research and Development; OVER ClinicalTrials.gov number, NCT00094575.).

Intensity of renal support in critically ill patients with acute kidney injury.

BACKGROUND: The optimal intensity of renal-replacement therapy in critically ill patients with acute kidney injury is controversial. METHODS: We randomly assigned critically ill patients with acute kidney injury and failure of at least one nonrenal organ or sepsis to receive intensive or less intensive renal-replacement therapy. The primary end point was death from any cause by day 60. In both study groups, hemodynamically stable patients underwent intermittent hemodialysis, and hemodynamically unstable patients underwent continuous venovenous hemodiafiltration or sustained low-efficiency dialysis. Patients receiving the intensive treatment strategy underwent intermittent hemodialysis and sustained low-efficiency dialysis six times per week and continuous venovenous hemodiafiltration at 35 ml per kilogram of body weight per hour; for patients receiving the less-intensive treatment strategy, the corresponding treatments were provided thrice weekly and at 20 ml per kilogram per hour. RESULTS: Baseline characteristics of the 1124 patients in the two groups were similar. The rate of death from any cause by day 60 was 53.6% with intensive therapy and 51.5% with less-intensive therapy (odds ratio, 1.09; 95% confidence interval, 0.86 to 1.40; P=0.47). There was no significant difference between the two groups in the duration of renal-replacement therapy or the rate of recovery of kidney function or nonrenal organ failure. Hypotension during intermittent dialysis occurred in more patients randomly assigned to receive intensive therapy, although the frequency of hemodialysis sessions complicated by hypotension was similar in the two groups. CONCLUSIONS: Intensive renal support in critically ill patients with acute kidney injury did not decrease mortality, improve recovery of kidney function, or reduce the rate of nonrenal organ failure as compared with less-intensive therapy involving a defined dose of intermittent hemodialysis three times per week and continuous renal-replacement therapy at 20 ml per kilogram per hour. (ClinicalTrials.gov number, NCT00076219.)

Leveraging longitudinal clinical laboratory results to improve prenatal care.

OBJECTIVES: To assess the impact of providing laboratory-generated near-real-time clinical insights for pregnant Medicaid members to managed care organization (MCO) care coordinators. STUDY DESIGN: A prospective, nonrandomized feasibility study was conducted over 11 months to examine the benefits of laboratory-generated clinical insights on prenatal care quality metrics and clinical outcomes. Measures included early identification of pregnancy and births to facilitate care, care gaps with prenatal laboratory testing, emergency department (ED) visits, preterm births, and neonatal intensive care unit (NICU) admissions and length of stay. METHODS: Weekly MCO care coordinators were provided a laboratory-generated prenatal targeted intervention module (TIM) to supplement their existing systems in a longitudinal, patient-centric format. Care coordinators contacted patients for enrollment in prenatal or postpartum services based on the TIM, which identified concomitant health conditions, missing prenatal care, and risks. RESULTS: The prenatal TIM identified 1355 pregnant members, 77% (n = 1040) of whom were detected in the first trimester. A total of 488 births were identified within 24 hours of parturition. Sixty-four percent of women had at least 80% of prenatal care gaps associated with laboratory testing closed. Women with ongoing prenatal care had fewer ED visits (17% vs 23%) and NICU admissions (11% vs 18%) compared with those without prenatal care. After adjusting for confounders, ongoing prenatal care had a borderline effect at decreasing the probability of having an ED visit and a NICU admission. CONCLUSIONS: An innovative collaboration between an MCO and a clinical laboratory improved quality measures for prenatal members enrolled in Medicaid.

The Value of Laboratory Information Augmenting a Managed Care Organization's Comprehensive Diabetes Care Efforts in New Mexico.

BACKGROUND: The National Committee on Quality Assurance's Healthcare Effectiveness Data and Information Set on Comprehensive Diabetes Care requires patients with diabetes obtain a hemoglobin A1c (Hb A1c) and urine albumin-to-creatinine ratio (ACR) test every year. To improve these measures, managed care organizations (MCOs) rely on claim and prescription data to identify members for care management. TriCore Reference Laboratories collaborated with Blue Cross Blue Shield of New Mexico (BCBSNM) to determine if laboratory information would augment BCBSNM's diabetes care management services. METHOD: In January 2018, BCBSNM provided its Medicaid enrollment file to TriCore for identifying members and determining their diabetes status by evaluating their recent Hb A1c results. Of the 6,138 members with diabetes, a random sample of 600 was extracted, and half were provided to BCBSNM to perform care management from January 18 to May 1, 2018. Completion of Hb A1c and ACR were measured. RESULTS: Significantly more (P = 0.03) study group members (25%) than control group members (18%) received an Hb A1c test. The study group (14%) also received more ACR tests than the control group (9%; P = 0.07). We then calculated the monetary penalty to which New Mexico Medicaid MCOs are subject, leading to the identification of additional value ($3,693,000) that clinical laboratories provide beyond the cost per test. CONCLUSION: Clinical laboratories play a critical role in healthcare, and this article demonstrates an approach for laboratories to collaborate with MCOs in their care management efforts. In addition, we calculate the value of this novel collaboration, which may play an integral role in laboratories' pursuit of value-based care.

Opportunity for Real-Time, Longitudinal Clinical Laboratory Data to Enhance Diabetes Disease Surveillance: A Cross-Sectional, Laboratory Database-Enabled Population Study.

BACKGROUND: Population disease surveillance can contribute to focused interventions to promote better disease management and prevention of noncommunicable diseases. METHODS: HbA1c results in TriCore Reference Laboratories' (TriCore) data repository from residents in New Mexico (NM) from January 2014 to May 2019 were used in the study. Using the Behavioral Risk Factor Surveillance System (BRFSS) as the gold standard, a linear regression model was used to develop a model to estimate NM's diabetes prevalence from HbA1cs. The American Diabetes Association guidelines HbA1c ranges were used to divide the population into groups according to their last HbA1c result, and patients were tracked by their TriCore identification number over the selected time period. RESULTS: The derived NM diabetes rate of 10.63%, 95% CI [10.1%-11.1%] was compared to the derived 10.4%, 95% CI [9.8%-11%] by the CDC. Moreover, TriCore's longitudinal data were able to track a large number of patients' transition between the different HbA1cs cut offs from 2014 to 2019. CONCLUSION: Findings of this study substantiate the value of the laboratory outside of the traditional fee per service lab result model and support a possible novel role for clinical laboratories to play in population health.

Measuring plastic pellet (nurdle) abundance on shorelines throughout the Gulf of Mexico using citizen scientists: Establishing a platform for policy-relevant research.

There is an increasing awareness of microplastics within the global problem of marine plastic pollution. In 2018, small plastic pellets or "nurdles" were observed on the beaches of Corpus Christi, Texas. A citizen science project, "Nurdle Patrol," was established by the Mission-Aransas National Estuarine Research Reserve to monitor the presence of nurdles, with volunteer interest enabling this project to expand across the Gulf of Mexico region. This case study describes the sampling methodology, the policy framework, and initial quantitative data from the citizen science project on nurdle distribution along the Gulf coast. A total of 2042 Nurdle Patrol surveys have been conducted by 744 citizen scientists covering shorelines from Mahahual, Mexico to Fort Jefferson, Florida. All 20 of the highest standardized nurdle counts were recorded at sites in Texas. Results can inform decision-maker response across regulatory scales and further research on nurdle pollution.

Measuring What Matters: How the Laboratory Contributes Value in the Opioid Crisis.

With over 20 years of the opioid crisis, our collective response has evolved to address the ongoing needs related to the management of opioid use and opioid use disorder. There has been an increasing recognition of the need for standardized metrics to evaluate organizational management and stewardship. The clinical laboratory, with a wealth of objective and quantitative health information, is uniquely poised to support opioid stewardship and drive valuable metrics for opioid prescribing practices and opioid use disorder (OUD) management. To identify laboratory-related insights that support these patient populations, a collection of 5 independent institutions, under the umbrella of the Clinical Laboratory 2.0 movement, developed and prioritized metrics. Using a structured expert panel review, laboratory experts from 5 institutions assessed possible metrics as to their relative importance, usability, feasibility, and scientific acceptability based on the National Quality Forum criteria. A total of 37 metrics spanning the topics of pain and substance use disorder (SUD) management were developed with consideration of how laboratory insights can impact clinical care. Monitoring these metrics, in the form of summative reports, dashboards, or embedded in laboratory reports themselves may support the clinical care teams and health systems in addressing the opioid crisis. The clinical insights and standardized metrics derived from the clinical laboratory during the opioid crisis exemplifies the value proposition of clinical laboratories shifting into a more active role in the healthcare system. This increased participation by the clinical laboratories may improve patient safety and reduce healthcare costs related to OUD and pain management.

Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial.

CONTEXT: Limited data are available to assess whether endovascular repair of abdominal aortic aneurysm (AAA) improves short-term outcomes compared with traditional open repair. OBJECTIVE: To compare postoperative outcomes up to 2 years after endovascular or open repair of AAA in a planned interim report of a 9-year trial. DESIGN, SETTING, AND PATIENTS: A randomized, multicenter clinical trial of 881 veterans (aged > or = 49 years) from 42 Veterans Affairs Medical Centers with eligible AAA who were candidates for both elective endovascular repair and open repair of AAA. The trial is ongoing and this report describes the period between October 15, 2002, and October 15, 2008. INTERVENTION: Elective endovascular (n = 444) or open (n = 437) repair of AAA. MAIN OUTCOME MEASURES: Procedure failure, secondary therapeutic procedures, length of stay, quality of life, erectile dysfunction, major morbidity, and mortality. RESULTS: Mean follow-up was 1.8 years. Perioperative mortality (30 days or inpatient) was lower for endovascular repair (0.5% vs 3.0%; P = .004), but there was no significant difference in mortality at 2 years (7.0% vs 9.8%, P = .13). Patients in the endovascular repair group had reduced median procedure time (2.9 vs 3.7 hours), blood loss (200 vs 1000 mL), transfusion requirement (0 vs 1.0 units), duration of mechanical ventilation (3.6 vs 5.0 hours), hospital stay (3 vs 7 days), and intensive care unit stay (1 vs 4 days), but required substantial exposure to fluoroscopy and contrast. There were no differences between the 2 groups in major morbidity, procedure failure, secondary therapeutic procedures, aneurysm-related hospitalizations, health-related quality of life, or erectile function. CONCLUSIONS: In this report of short-term outcomes after elective AAA repair, perioperative mortality was low for both procedures and lower for endovascular than open repair. The early advantage of endovascular repair was not offset by increased morbidity or mortality in the first 2 years after repair. Longer-term outcome data are needed to fully assess the relative merits of the 2 procedures. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00094575.

Accumulation and distribution of marine debris on barrier islands across the northern Gulf of Mexico.

Marine debris is an economic, environmental, human health, and aesthetic problem posing a complex challenge to communities around the globe. To better document this problem in the Gulf of Mexico we monitored the occurrence and accumulation rate of marine debris at twelve sites on nine barrier islands from North Padre Island, Texas to Santa Rosa, Florida. With this information we are investigating three specific questions: (1) what are the major types/sources of marine debris; (2) does debris deposition have seasonal oscillations; and (3) how does debris deposition change spatially? Several trends emerged; plastic composed 69-95% of debris; there was a significant increase in debris accumulation during the spring and summer seasons; accumulation rates were ten times greater in Texas than the other Gulf States throughout the year; and the amount of debris accumulating along the shoreline could be predicted with high confidence in areas with high freshwater influx.

Improving the Delivery of Healthcare through Clinical Diagnostic Insights: A Valuation of Laboratory Medicine through "Clinical Lab 2.0".

BACKGROUND: As healthcare payment and reimbursement begin to shift from a fee-for-service to a value-based model, ancillary providers including laboratories must incorporate this into their business strategy. Laboratory medicine, while continuing to support a transactional business model, should expand efforts to include translational data analytics, proving its clinical and economic valuation. Current literature in this area is limited. CONTENT: This article is a summary of how laboratory medicine can support value-based healthcare. Population health management is emerging as a method to support value-based healthcare by aggregating patient information, providing data analysis, and contributing to clinical decision support. Key issues to consider with a laboratory-developed population health management model are discussed, including changing reimbursement models, the use of multidisciplinary committees, the role of specialists in data analytics and programming, and barriers to implementation. Examples of data considerations and value are given. SUMMARY: Laboratory medicine is able to provide meaningful clinical diagnostic insights for population health initiatives that result in improved short- and long-term patient outcomes and drive cost-effective care. Opportunities include data analysis with longitudinal laboratory data, identification of patient-specific targeted interventions, and development of clinical decision support tools. Laboratories will need to leverage the skills and knowledge of their multidisciplinary staff, along with their extensive patient data sets, through innovative analytics to meet these objectives.

Assessing coastal wetland vulnerability to sea-level rise along the northern Gulf of Mexico coast: Gaps and opportunities for developing a coordinated regional sampling network.

Coastal wetland responses to sea-level rise are greatly influenced by biogeomorphic processes that affect wetland surface elevation. Small changes in elevation relative to sea level can lead to comparatively large changes in ecosystem structure, function, and stability. The surface elevation table-marker horizon (SET-MH) approach is being used globally to quantify the relative contributions of processes affecting wetland elevation change. Historically, SET-MH measurements have been obtained at local scales to address site-specific research questions. However, in the face of accelerated sea-level rise, there is an increasing need for elevation change network data that can be incorporated into regional ecological models and vulnerability assessments. In particular, there is a need for long-term, high-temporal resolution data that are strategically distributed across ecologically-relevant abiotic gradients. Here, we quantify the distribution of SET-MH stations along the northern Gulf of Mexico coast (USA) across political boundaries (states), wetland habitats, and ecologically-relevant abiotic gradients (i.e., gradients in temperature, precipitation, elevation, and relative sea-level rise). Our analyses identify areas with high SET-MH station densities as well as areas with notable gaps. Salt marshes, intermediate elevations, and colder areas with high rainfall have a high number of stations, while salt flat ecosystems, certain elevation zones, the mangrove-marsh ecotone, and hypersaline coastal areas with low rainfall have fewer stations. Due to rapid rates of wetland loss and relative sea-level rise, the state of Louisiana has the most extensive SET-MH station network in the region, and we provide several recent examples where data from Louisiana's network have been used to assess and compare wetland vulnerability to sea-level rise. Our findings represent the first attempt to examine spatial gaps in SET-MH coverage across abiotic gradients. Our analyses can be used to transform a broadly disseminated and unplanned collection of SET-MH stations into a coordinated and strategic regional network. This regional network would provide data for predicting and preparing for the responses of coastal wetlands to accelerated sea-level rise and other aspects of global change.

Endosymbiotic heterocystous cyanobacteria synthesize different heterocyst glycolipids than free-living heterocystous cyanobacteria.

The heterocysts of limnetic nitrogen-fixing filamentous cyanobacteria contain unique glycolipids in their cell wall that create the distinctive gas impermeability of the heterocyst cell wall as well as serve as biomarker lipids for these microbes. It has been assumed that marine free-living and endosymbiotic cyanobacteria synthesize the same glycolipids although they have not been investigated in any detail. Here we report the glycolipid composition of several marine free-living heterocystous cyanobacteria as well as the heterocystous endosymbiont Richelia intracellularis found in the biogeochemically important diatoms Hemiaulus hauckii and Hemiaulus membranaceus. In the marine cyanobacteria Nostoc muscorum and Calothrix sp., we detected the same glycolipids as found in freshwater representatives of these genera. However, we did not detect these glycolipids in the Hemiaulus-Richelia association. Instead, we identified glycolipids which comprised a C5 sugar, ribose, rather than the C6 sugars normally encountered in glycolipids of free-living cyanobacteria. In addition, the glycolipids had slightly longer chain lengths (C30 and C32 versus C26 and C28) in the aglycone moiety. The different glycolipid composition of the marine endosymbotic heterocystous cyanobacteria compared to their free-living counterparts may be an adaptation to the high intracellular O2 concentrations within their host. These glycolipids may provide unique tracers for the presence of these microbes in marine environments and permit exploration of the evolutionary origins of these symbioses.

Sudden sensorineural hearing loss associated with vardenafil.

The phosphodiesterase type 5 (PDE-5) inhibitors-sildenafil, vardenafil, and tadalafil-are used primarily in erectile dysfunction, but sildenafil is also indicated for pulmonary hypertension. Common adverse effects of vardenafil include headache, flushing, nasal congestion, dyspepsia, and nausea. Recently, PDE-5 inhibitors have been associated with adverse vision effects, and emerging evidence now indicates that they may also be responsible for hearing changes and hearing loss. We describe a patient who developed unilateral sudden sensorineural hearing loss possibly related to the use of vardenafil for erectile dysfunction. To our knowledge, only one other case of hearing loss related to this drug class has been published. Our patient was a 57-year-old man who came to the emergency department with right-sided mild-to-moderate hearing loss in the 500-3000-Hz range, confirmed by audiogram, that occurred after ingestion of vardenafil. The patient was hospitalized 2 days later for administration of intravenous dexamethasone, followed by oral prednisone. He reported that his hearing had improved on the fourth hospital day and was discharged 3 days later, continuing to taper the prednisone on an outpatient basis. A repeat audiogram after 10 days of corticosteroid therapy confirmed that his hearing in the 500-3000-Hz range was within normal limits. Use of the Naranjo adverse drug reaction probability scale indicated a possible (score of 3) adverse reaction of sudden sensorineural hearing loss associated with vardenafil consumption. We also performed an analysis of hearing loss cases related to PDE-5 inhibitors in the United States Food and Drug Administration's Adverse Event Reporting System database to compare the characteristics of our patient with those of other reported adverse event cases. Based on the temporal relation of the sudden sensorineural hearing loss to this patient's drug consumption, we propose that the vardenafil is a likely cause of the hearing loss. This case provides further evidence that PDE-5 inhibitor consumption should be considered as a possible cause in patients presenting with sudden sensorineural hearing loss.

Quality of life of patients with advanced HIV/AIDS: measuring the impact of both AIDS-defining events and non-AIDS serious adverse events.

OBJECTIVE: To investigate the relative magnitude and duration of impact of AIDS-defining events (ADEs) and non-AIDS serious adverse events (SAEs) on health-related quality of life (HRQoL) among patients with advanced HIV/AIDS. METHODS: We use data from OPTIMA (OPTions In Management with Antiretrovirals), a multinational, randomized, open, control, clinical management trial of treatment strategies for patients with multidrug-resistant HIV and advanced immune disease. Longitudinal models were used to determine the effects of ADEs and SAEs on HRQoL across periods before, during, and after event onset. The Medical Outcomes Study HIV Health Survey (MOS-HIV) physical and mental health summary scores (MOS-PHS and MOS-MHS), EQ-5D, and the Health Utilities Index Mark 3 HRQoL measures were all assessed at regular follow-up intervals during the trial. RESULTS: ADEs occurred much less frequently than SAEs (n = 147 vs. n = 821) in the study sample population of 368 patients, during median follow-up of 3.96 years. Although both ADEs and SAEs had significant negative impacts on HRQoL, SAEs had at least as large an impact upon HRQoL as ADEs when both were included in a multivariate linear regression model, controlling for other covariates. However, the effect of ADEs on HRQoL was more persistent, with larger magnitude of effect across all instruments in time intervals further from the onset of the event. CONCLUSIONS: Non-AIDS SAEs occurring in patients with late-stage HIV/AIDS seem to have at least as important an immediate impact on patient HRQoL as ADEs; however, the impact of ADEs seems to be more persistent. Our findings call for a greater emphasis on the detection and active prevention of non-AIDS SAEs in patients with late-stage HIV/AIDS.