US Healthcare Settings Research Articles

Uptake of and Factors Associated With Direct-acting Antiviral Therapy Among Patients in the Chronic Hepatitis Cohort Study, 2014 to 2015.

Limited information is available describing the uptake of direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection among patients in general US health care settings. We determined the proportion of HCV-infected patients in the Chronic Hepatitis Cohort Study prescribed DAAs in 2014, who initiated treatment and identified characteristics associated with treatment initiation. Uptake was defined as the proportion of HCV-infected patients with at least 1 clinical encounter in 2013 who were prescribed a DAA regimen during 2014 and initiated the regimen by August 2015. Using multivariable analysis, we examined demographic and clinical characteristics associated with receipt of DAAs. The cohort comprised 9508 patients; 544 (5.7%) started a DAA regimen. Higher annual income [adjusted odds ratios (aOR) 2.3 for income>$50K vs. <$30K], higher Fibrosis-4 score (aORs, 2.1, 2.0, and 1.4 for Fibrosis-4, >5.88, 3.25 to 5.88, 2.0 to 3.25, respectively, vs. <2.0), genotype 2 infection (aOR 2.2 vs. genotype 1), pre-2014 treatment failure (aOR 2.0 vs. treatment-naive), and human immunodeficiency virus (HIV) coinfection (aOR 1.8 vs. HCV monoinfection) were associated with DAA initiation. Black race/ethnicity (aOR 0.7 vs. whites) and Medicaid coverage (aOR 0.5 vs. private insurance) were associated with noninitiation. Sex, age, comorbidity, previous liver transplant, and duration of follow-up were not associated with receipt of DAAs. Among patients in these general US health care settings, uptake of DAA therapy was low in 2014, and especially so among minority and Medicaid patients. Systemic efforts to improve access to DAAs for all patients are essential to reduce morbidity and mortality from HCV infection.

Effect of Low Back Pain Risk-Stratification Strategy on Patient Outcomes and Care Processes: the MATCH Randomized Trial in Primary Care.

The STarT Back strategy for categorizing and treating patients with low back pain (LBP) improved patients' function while reducing costs in England. This trial evaluated the effect of implementing an adaptation of this approach in a US setting. The Matching Appropriate Treatments to Consumer Healthcare needs (MATCH) trial was a pragmatic cluster randomized trial with a pre-intervention baseline period. Six primary care clinics were pair randomized, three to training in the STarT Back strategy and three to serve as controls. Adults receiving primary care for non-specific LBP were invited to provide data2weeks after their primary care visit and follow-up data 2 and 6months (primary endpoint) later. The STarT Back risk-stratification strategy matches treatments for LBP to physical and psychosocial obstacles to recovery using patient-reported data (the STarT Back Tool) to categorize patients' risk of persistent disabling pain. Primary care clinicians in the intervention clinics attended six didactic sessions to improve their understanding LBP management and received in-person training in the use of the tool that had been incorporated into the electronic health record (EHR). Physical therapists received 5days of intensive training. Control clinics received no training. Primary outcomes were back-related physical function and pain severity. Intervention effects were estimated by comparing mean changes in patient outcomes after 2 and 6months between intervention and control clinics. Differences in change scores by trial arm and time period were estimated using linear mixed effect models. Secondary outcomes included healthcare utilization. Although clinicians used the tool for about half of their patients, they did not change the treatments they recommended. The intervention had no significant effect on patient outcomes or healthcare use. A resource-intensive intervention to support stratified care for LBP in a US healthcare setting had no effect on patient outcomes or healthcare use. National Clinical Trial Number NCT02286141.

PSY44 - Economic Burden of Myasthenia Gravis in the US: A Literature Review

To collate evidence from published studies evaluating the economic burden of myasthenia gravis (MG) in the US. A literature search was conducted in Embase®, MEDLINE® and the Cochrane Library to identify recent evidence (2007–2017). Two reviewers assessed study eligibility, with discrepancies reconciled by a third independent reviewer. Studies were included if published in English and reported economic burden associated with MG within a US healthcare setting. Of the 763 publications retrieved, 12 met the predefined inclusion criteria. Plasmapheresis and intravenous immunoglobulin (IVIG) were the key therapies assessed across six studies. Opila et al. 2015 reported that plasmapheresis increased the hospitalization charges and stay in geriatric patients but not for the adult patients relative to IVIG. Hasan et al. 2012 reported that, over 18 years, the use of IVIG increased (p<0.0001) hospitalization cost for geriatric patients ($7,714 in 1994 to $70,110 in 2009). In two other studies, plasmapheresis increased the hospitalization cost per patient for both adult and geriatric patients; p<0.0001. The hospitalization cost for geriatric and adult patients receiving plasmapheresis was $21,212 and $31,491 in 1993–1994, increasing to $86,430 and $104,143 in 2007–2009, respectively. However, average length of hospitalization (days) decreased from 11.16 and 15.66 in 1992–1993 to 5.30 and 10.37 in 2002–2009, for geriatric and adult patients, respectively; p<0.05 (Sheikh et al., 2013; Elmoursi et al., 2014). Furthermore, Souayah et al., 2009 reported an increase in hospital charges ($84,100 to $118,000) but a minimal increase in hospital stay (21 to 22 days) following use of mechanical ventilation over a span of 12 years (1991–2002); p=0.0001. Despite a decrease in hospital stay, there has been a substantial increase in hospitalization cost. The use of mechanical ventilation, plasmapheresis and IVIG are the major factors contributing to the high economic burden.

Intermittent pneumatic compression is a cost-effective method of orthopedic postsurgical venous thromboembolism prophylaxis.

BackgroundVenous thromboembolism (VTE) is a major complication after lower-limb arthroplasty that increases costs and reduces patient’s quality of life. Using anticoagulants for 10–35 days following arthroplasty is the standard prophylaxis, but its cost-effectiveness after accounting for bleeding complications remains unproven.MethodsA comprehensive, clinical model of VTE was created using the incidences, clinical effects (including bleeding), and costs of VTE and prophylaxis from randomized controlled trials, meta-analyses, and large observational studies. Over 50 years, the total health care costs and clinical impact of three prophylaxis strategies, that are as follows, were compared: low-molecular-weight heparin (LMWH) alone, intermittent pneumatic compression (IPC), and IPC with LMWH (IPC+LMWH). The cost per VTE event that was avoided and cost per quality-adjusted life year (QALY) gained in both the US and Australian health care settings were calculated.ResultsFor every 2,000 patients, the expected number of VTE and major bleeding events with LMWH were 151 and 6 in the USA and 160 and 46 in Australia, resulting in a mean of 11.3 and 9.1 QALYs per patient, respectively. IPC reduced the expected VTE events by 11 and 8 in the USA and Australia, respectively, compared to using LMWH alone. IPC reduced major bleeding events compared to LMWH, preventing 1 event in the US and 7 in Australia. IPC+LMWH only reduced VTE events. Neither intervention substantially impacted QALYs but both increased QALYs versus LMWH. IPC was cost-effective followed by IPC+LMWH.ConclusionIPC and IPC+LMWH are cost-effective versus LMWH after lower-limb arthroplasty in the USA and Australia. The choice between IPC and IPC+LMWH depends on expected bleeding risks.

A cost-effectiveness analysis of varenicline for smoking cessation using data from the EAGLES trial.

BackgroundThe cost-effectiveness of varenicline has been demonstrated in the US health care setting using the Benefits of Smoking Cessation on Outcomes (BENESCO) model to simulate the lifetime direct costs and consequences of a hypothetical cohort of US adult smokers who make a single attempt to quit. The aim of this study was to undertake an updated cost-effectiveness analysis, using current epidemiology inputs and recently published smoking cessation data from the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES), the largest clinical trial of smoking cessation pharmacotherapies conducted to date.MethodsBENESCO is a Markov model simulating the effect of a single attempt to quit smoking on four smoking-related diseases: coronary heart disease, stroke, chronic obstructive lung disease, and lung cancer. Inputs were updated to include efficacy from EAGLES and newer data for the epidemiology of smoking in the US, the epidemiology and direct treatment costs of the four morbidities, and the costs of the interventions. Analyses compared varenicline, bupropion, nicotine replacement therapy (NRT) patch, and placebo with regard to the incidence of smoking-related morbidity, the incidence of smoking-related mortality, and cost-effectiveness at a time horizon from 2 years to lifetime.ResultsThe study cohort comprised of 18,394,068 US adult smokers who made a single quit attempt during the first year of the model. For varenicline, there were an estimated 319,730 fewer smoking-related morbidities at the lifetime compared with placebo. Similarly, smoking-related mortality decreased by 198,240 subjects when varenicline was compared with placebo. For the same time horizon, varenicline was more effective and less costly, ie, dominant, compared with all comparators in the cost-effectiveness analysis.ConclusionBased on the BENESCO model, smoking cessation with varenicline results in reduced incidence of smoking-related morbidity and mortality compared with other smoking cessation interventions and remains a cost-effective strategy in the US population.

Public Health Response to US Cases of Candida auris, a Globally Emerging, Multidrug-Resistant Yeast, 2013–2017

Background Candida auris is an often multidrug-resistant yeast that causes invasive infections and, unlike most Candida species, spreads in healthcare facilities. CDC released a clinical alert in June 2016 requesting reporting of C. auris cases. We investigated cases to contain transmission and inform prevention measures for this novel organism.Methods Clinical cases were defined as C. auris from any clinical specimen from a patient in the United States. Response to cases included implementation of infection control measures, enhanced cleaning and disinfection, and testing of close contacts for C. auris colonisation (isolation from a person’s axilla or groin was defined as a screening case). Microbiology records were reviewed at reporting facilities for missed cases. All isolates were forwarded to CDC for confirmation, antifungal susceptibility testing, and whole-genome sequencing (WGS).ResultsAs of April 13, 2017, 61 clinical cases of C. auris were reported from six states: New York (39), New Jersey (15), Illinois (4), Indiana (1), Maryland (1), and Massachusetts (1). All but two occurred since 2016 (Figure). An additional 32 screening cases were identified among contacts. Median age of clinical case-patients was 70 years (range 21–96); 56% were male. Nearly, all had underlying medical conditions and extensive exposure to healthcare facilities before infection. Most clinical isolates were from blood (38, 62%), followed by urine (8, 13%) and respiratory tract (5, 8%). Among the first 35 isolates, 30 (86%) were resistant to fluconazole, 15 (43%) to amphotericin B, and one (3%) to caspofungin. No isolate was resistant to all three. WGS revealed isolates from each state were highly related and different from other states, suggestive of transmission. Microbiology record reviews did not identify additional cases before 2016.Conclusion C. auris is an emerging pathogen, with similarities to multidrug-resistant bacteria, that has been transmitted in US healthcare settings. CDC and public health partners are committed to prompt and aggressive action through investigation of cases and heightened infection control practices to halt its spread.Disclosures All authors: No reported disclosures.

Distribution of disease phase, treatment prescription and severe liver disease among 1598 patients with chronic hepatitis B in the Chronic Hepatitis Cohort Study, 2006-2013.

Limited information exists regarding the distribution of disease phases, treatment prescription and severe liver disease among patients with chronic hepatitis B (CHB) in US general healthcare settings. To determine the distribution of disease phases, treatment prescription and severe liver disease among patients with CHB in general US healthcare settings. We analysed demographic and clinical data collected during 2006-2013 from patients with confirmed CHB in the Chronic Hepatitis Cohort Study, an observational cohort study involving patients from healthcare organisations in Michigan, Pennsylvania, Oregon and Hawaii. CHB phases were classified according to American Association for the Study of Liver Disease guidelines. Of 1598 CHB patients with ≥12 months of follow-up (median 6.3 years), 457 (29%) were immune active during follow-up [11% hepatitis B e antigen (HBeAg)-positive, 16% HBeAg-negative, and 2% HBeAg status unknown], 10 (0.6%) were immune tolerant, 112 (7%) were inactive through the duration of follow-up and 886 (55%) were phase indeterminate. Patients with cirrhosis were identified within each group (among 21% of immune active, 3% of inactive and 9% of indeterminate phase patients) except among those with immune-tolerant CHB. Prescription of treatment was 59% among immune active patients and 84% among patients with cirrhosis and hepatitis B virus (HBV) DNA >2000 IU/mL. Approximately, one-third of the cohort had active disease during follow-up; 60% of eligible patients were prescribed treatment. Our findings underscore the importance of ascertainment of fibrosis status in addition to regular assessment of ALT and HBV DNA levels.

Recommendations from the EGAPP Working Group: does the use of Oncotype DX tumor gene expression profiling to guide treatment decisions improve outcomes in patients with breast cancer?

of The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group found insufficient evidence to recommend for or against the use of Oncotype DX testing to guide chemotherapy treatment decisions in women with hormone receptor-positive, lymph node-negative, or lymph node-positive early breast cancer who are receiving endocrine therapy. This recommendation statement updates a 2009 EGAPP statement on the use of gene expression profiling tests in breast cancer. Evidence of clinical validity for Oncotype DX was confirmed as adequate. With regard to clinical utility, although there was evidence from prospective retrospective studies that the Oncotype DX test predicts benefit from chemotherapy, and there was adequate evidence that the use of Oncotype DX gene expression profiling in clinical practice changes treatment decisions regarding chemotherapy, no direct evidence was found that the use of Oncotype DX testing leads to improved clinical outcomes. In women with early-stage invasive breast cancer, gene expression profiling is increasingly being used as an aid to estimate the likely benefit from chemotherapy treatment. In a previous recommendation statement, the EGAPP Working Group (EWG) found adequate evidence for clinical validity of some gene expression profiling tests in predicting distant disease recurrence in women with early-stage, hormone receptor-positive, lymph-node-negative breast cancer who are treated with tamoxifen, but insufficient evidence that use of these tests for decisions about chemotherapy treatment has clinical utility. The current recommendation statement updates these findings for Oncotype DX and extends them to the population of women with lymph node-positive disease, using evidence from recent systematic reviews and other sources. The previous recommendation statement found that evidence was inadequate to enable quantitative determination of the analytic validity of Oncotype DX. Analytic validity was not reconsidered in the updated recommendation statement because there remains no gold-standard test for comparison. The EWG found that new evidence published since the original evidence review supports the clinical validity of Oncotype DX in predicting risk of distant metastases in women with hormone receptor-positive, early-stage breast cancer that is either node-negative or node-positive. No direct evidence was found that use of Oncotype DX tumor gene expression profiling to guide treatment decisions improves clinical outcomes in women with early breast cancer. There is indirect evidence, from prospective retrospective studies on archived tissue samples from randomized controlled trials, that the Oncotype DX test can predict benefit from chemotherapy. Large, prospective, randomized, controlled trials currently in progress may provide evidence of clinical utility. Until definitive evidence for clinical utility is available, clinicians must decide on a case-by-case basis whether to offer the test to patients. Although Oncotype DX testing has been reported, on the basis of economic modeling studies, to be cost-effective in several different health-care systems and to save costs in the US health-care setting, studies were based on assumptions regarding the clinical utility of the test that require confirmation by clinical trial results.Genet Med 18 8, 770-779.

Delays in diagnosis and treatment of lung cancer: Lessons from US healthcare settings

YZ is supported by an Academic Clinical Fellowship in General Practice, awarded by Health Education East of England. GL is supported by a Cancer Research UK Clinician Scientist Fellowship (A18180).

A time-driven activity-based costing model to improve health-care resource use in Mirebalais, Haiti

BackgroundIn resource-limited settings, efficiency is crucial to maximise resources available for patient care. Time driven activity-based costing (TDABC) estimates costs directly from clinical and administrative processes used in patient care, thereby providing valuable information for process improvements. TDABC is more accurate and simpler than traditional activity-based costing because it assigns resource costs to patients based on the amount of time clinical and staff resources are used in patient encounters. Other costing approaches use somewhat arbitrary allocations that provide little transparency into the actual clinical processes used to treat medical conditions. TDABC has been successfully applied in European and US health-care settings to facilitate process improvements and new reimbursement approaches, but it has not been used in resource-limited settings. We aimed to optimise TDABC for use in a resource-limited setting to provide accurate procedure and service costs, reliably predict financing needs, inform quality improvement initiatives, and maximise efficiency. MethodsA multidisciplinary team used TDABC to map clinical processes for obstetric care (vaginal and caesarean deliveries, from triage to post-partum discharge) and breast cancer care (diagnosis, chemotherapy, surgery, and support services, such as pharmacy, radiology, laboratory, and counselling) at Hôpital Universitaire de Mirebalais (HUM) in Haiti. The team estimated the direct costs of personnel, equipment, and facilities used in patient care based on the amount of time each of these resources was used. We calculated inpatient personnel costs by allocating provider costs per staffed bed, and assigned indirect costs (administration, facility maintenance and operations, education, procurement and warehouse, bloodbank, and morgue) to various subgroups of the patient population. This study was approved by the Partners in Health/Zanmi Lasante Research Committee. FindingsThe direct cost of an uncomplicated vaginal delivery at HUM was US$62 and the direct cost of a caesarean delivery was US$249. The direct costs of breast cancer care (including diagnostics, chemotherapy, and mastectomy) totalled US$1393. A mastectomy, including post-anaesthesia recovery and inpatient stay, totalled US$282 in direct costs. Indirect costs comprised 26–38% of total costs, and salaries were the largest percentage of total costs (51–72%). InterpretationAccurate costing of health services is vital for financial officers and funders. TDABC showed opportunities at HUM to optimise use of resources and reduce costs—for instance, by streamlining sterilisation procedures and redistributing certain tasks to improve teamwork. TDABC has also improved budget forecasting and informed financing decisions. HUM leadership recognised its value to improve health-care delivery and expand access in low-resource settings. FundingBoston Children's Hospital, Harvard Business School, and Partners in Health.

Integrating intimate partner violence assessment and intervention into healthcare in the United States: a systems approach.

The Institute of Medicine, United States Preventive Services Task Force (USPSTF), and national healthcare organizations recommend screening and counseling for intimate partner violence (IPV) within the US healthcare setting. The Affordable Care Act includes screening and brief counseling for IPV as part of required free preventive services for women. Thus, IPV screening and counseling must be implemented safely and effectively throughout the healthcare delivery system. Health professional education is one strategy for increasing screening and counseling in healthcare settings, but studies on improving screening and counseling for other health conditions highlight the critical role of making changes within the healthcare delivery system to drive desired improvements in clinician screening practices and health outcomes. This article outlines a systems approach to the implementation of IPV screening and counseling, with a focus on integrated health and advocacy service delivery to support identification and interventions, use of electronic health record (EHR) tools, and cross-sector partnerships. Practice and policy recommendations include (1) ensuring staff and clinician training in effective, client-centered IPV assessment that connects patients to support and services regardless of disclosure; (2) supporting enhancement of EHRs to prompt appropriate clinical care for IPV and facilitate capturing more detailed and standardized IPV data; and (3) integrating IPV care into quality and meaningful use measures. Research directions include studies across various health settings and populations, development of quality measures and patient-centered outcomes, and tests of multilevel approaches to improve the uptake and consistent implementation of evidence-informed IPV screening and counseling guidelines.

Outbreaks of Infections Associated With Drug Diversion by US Health Care Personnel

ObjectiveTo summarize available information about outbreaks of infections stemming from drug diversion in US health care settings and describe recommended protocols and public health actions. Patients and MethodsWe reviewed records at the Centers for Disease Control and Prevention related to outbreaks of infections from drug diversion by health care personnel in US health care settings from January 1, 2000, through December 31, 2013. Searches of the medical literature published during the same period were also conducted using PubMed. Information compiled included health care setting(s), infection type(s), specialty of the implicated health care professional, implicated medication(s), mechanism(s) of diversion, number of infected patients, number of patients with potential exposure to blood-borne pathogens, and resolution of the investigation. ResultsWe identified 6 outbreaks over a 10-year period beginning in 2004; all occurred in hospital settings. Implicated health care professionals included 3 technicians and 3 nurses, one of whom was a nurse anesthetist. The mechanism by which infections were spread was tampering with injectable controlled substances. Two outbreaks involved tampering with opioids administered via patient-controlled analgesia pumps and resulted in gram-negative bacteremia in 34 patients. The remaining 4 outbreaks involved tampering with syringes or vials containing fentanyl; hepatitis C virus infection was transmitted to 84 patients. In each of these outbreaks, the implicated health care professional was infected with hepatitis C virus and served as the source; nearly 30,000 patients were potentially exposed to blood-borne pathogens and targeted for notification advising testing. ConclusionThese outbreaks revealed gaps in prevention, detection, and response to drug diversion in US health care facilities. Drug diversion is best prevented by health care facilities having strong narcotics security measures and active monitoring systems. Appropriate response includes assessment of harm to patients, consultation with public health officials when tampering with injectable medication is suspected, and prompt reporting to enforcement agencies.

The Quality of Primary Care Experienced by Health Center Patients

We investigated the quality of the primary care experienced by health center (HC) patients and investigated whether race/ethnicity and insurance coverage were significantly associated with patients' experiences. Cross-sectional data came from the 2009 Health Center Patient Survey. Outcomes included 10 measures of patients' experiences with primary care domains, including: (1) accessibility, (2) communication, (3) comprehensiveness, and (4) coordination of care. Patients who received care at HCs reported high-quality primary care, particularly regarding accessibility and communication. For example, more than 94% of patients reported that their HC location was convenient, and more than 94% reported that their provider adequately explained what they wanted to know. After adjusting for sociodemographic characteristics, few significant racial/ethnic and insurance-related disparities were observed. In the domains of comprehensiveness and coordination, insured patients generally had better experiences than uninsured patients. For instance, Medicaid-insured patients had higher odds of reporting that HC staff helped them arrange medical appointments at other health care settings than uninsured patients (odds ratio, 2.04; 95% confidence interval, 1.35-3.09). As safety-net providers for vulnerable populations, HCs provide high-quality primary care and do not exhibit the extent of disparities that exist in other US health care settings. Continued efforts are necessary to address insurance-related disparities, particularly among uninsured patients.

Crossing Borders: One World, Global Health

Crossing Borders: One World, Global Health

Diagnosis, Costs, and Utilization for Psychogenic Non-Epileptic Seizures in a US Health Care Setting

Psychogenic non-epileptic seizures (PNES) pose a substantial burden to patients and the health care system, due to long diagnostic and treatment delays. This study used medical chart notes from 103 patients to shed light on the diagnostic process. Electronic medical records and cost data from a US health system were also used to investigate costs and utilization for the 12-months before and after PNES diagnosis. The results show that accurate diagnosis was typically achieved via the use of multiple medical tests, including vEEG, magnetic resonance imaging (MRI), and computed tomography (CT) scans, as well as historical diagnostic and clinical information. In the year following PNES diagnosis, a decline in average visits (-1.45) and costs (-$1784) were observed. The largest cost savings were seen in neurology care and inpatient stays. This study has implications for timely and accurate diagnosis of PNES, which may decrease the overall health care burden for individuals and the health care system.

Patient Notification for Bloodborne Pathogen Testing due to Unsafe Injection Practices in the US Health Care Settings, 2001–2011

Syringe reuse and other unsafe injection practices can expose patients to bloodborne pathogens (eg, hepatitis B and C viruses and human immunodeficiency virus). Evidence of such infection control lapses has resulted in patient notifications, but the scope and magnitude of these events have not been well characterized. To summarize patient notification events resulting from unsafe injection practices in the US health care settings. We examined records of events that involved communications to groups of patients, conducted during 2001-2011, advising bloodborne pathogen testing stemming from potential exposures to unsafe injection practices. We identified 35 patient notification events related to unsafe injection practices in at least 17 states, resulting in an estimated total of 130,198 patients notified. Among the identified notification events, 83% involved outpatient settings and 74% occurred since 2007, including the 4 largest events (>5000 patients per event). The primary breach identified (≥16 events; 44%) was syringe reuse to access shared medications (eg, single-dose or multidose vials). Twenty-two (63%) notifications stemmed from the identification of viral hepatitis transmission, whereas 13 (37%) were prompted by the discovery of unsafe injection practices, absent evidence of bloodborne pathogen transmission. Unsafe injection practices represent a form of medical error that have manifested as large-scale adverse events, affecting thousands of patients in a wide variety of health care settings. Our findings suggest that increased oversight and attention to basic infection control are needed to maintain patient safety, along with research to identify best practices for triggering and managing patient notifications.

Perspectives on the ethical concerns and justifications of the 2006 Centers for Disease Control and Prevention HIV testing recommendations

BackgroundIn 2006, the Centers for Disease Control and Prevention (CDC) recommended three changes to HIV testing methods in US healthcare settings: (1) an opt-out approach, (2) removal of separate signed consent, and (3) optional HIV prevention counseling. These recommendations led to a public debate about their moral acceptability.MethodsWe interviewed 25 members from the fields of US HIV advocacy, care, policy, and research about the ethical merits and demerits of the three changes to HIV testing methods. We performed a qualitative analysis of the participant responses in the interviews and summarized the major themes.ResultsIn general, arguments in favor of the methods were based upon their ultimate contribution to increasing HIV testing and permitting the consequent benefits of identifying those who are HIV infected and linking them to further care.ConclusionsThe prevailing theme of ethical concern focused on suspicions that the methods might not be properly implemented, and that further safeguards might be needed.

Injection practices among clinicians in United States health care settings

Improper use of syringes, needles, and medication vials has resulted in patient-to-patient transmission of bloodborne pathogens, including hepatitis C virus. This study examined the injection practices of health care providers to identify trends and target opportunities for education on safe practices. An on-line survey was conducted in May and June 2010 of clinicians in US health care settings that prepare and/or administerparenteral medications. The majority of the 5446 eligible respondents reported injection practices consistent with current recommendations. However, the following unsafe practices were identified: 6.0% "sometimes or always" use single-dose/single-use vials for more than 1 patient; 0.9% "sometimes or always" reuse a syringe but change the needle for use on a second patient; 15.1% reuse a syringe to enter a multidose vial and then 6.5% save that vial for use on another patient (1.1% overall). Unsafe injection practices represent an ongoing threat to patient safety. Ensuring safe injection practices in all health care settings will require a multifaceted approach that focuses on surveillance, oversight, enforcement, and continuing education.

Method for Evaluating the Relative Efficiency of Selected N95 Respirators and Surgical Masks to Prevent the Inhalation of Airborne Vegetative Cells by Healthcare Personnel

Aerosol droplet- and airborne-transmitted diseases are an important healthcare concern. The anthrax attacks of 2001, severe acute respiratory syndrome outbreaks in 2003 which resulted in transmission to numerous healthcare personnel (HCP) and concerns about smallpox as a bioterrorist agent have contributed to heightened concern about airborne infectious agents. Respirators and surgical masks can provide respiratory protection against such airborne diseases but their efficacy needs to be assessed. This study describes a method for quantitatively assessing the relative efficiency of respiratory protective equipment (RPE) when challenged with a bioaerosol. Five surgical masks, three N95 respirators and three surgical N95 respirators were evaluated. All are commercially available and used in US healthcare settings. Bacterial aerosols of vegetative Bacillus anthracis strain Sterne 34F2 (a surrogate for pathogenic B. anthracis) were generated with a six-jet Collison nebuliser. To mimic human respiratory breathing, an automated breathing simulator (ABS) calibrated to normal tidal volume and active breathing rate (500 mL/breath and 20 breath/min, respectively) was used. Respirators were placed on manikin head-forms designed for use in cardiopulmonary resuscitation training and used in our investigation as surrogates for HCP. The method showed that a Collison nebuliser could generate monodisperse bacterial aerosol to effectively test RPE total inward leakage. Also, the AGI-30 air samplers, combined with the ABS, provided an accurate method of quantifying RPE relative efficiency. For the 11 RPE this ranged from 34% to 69% with statistically significant differences between several RPE models. We conclude that neither RPE type nor brand name was an indicator of RPE relative efficiency.

Is it time to change our HIV testing policy in health care facilities?

The annual number of AIDS deaths declined substantially in the USA following introduction of highly active antiretroviral therapy (HAART) in 1995 but has remained stable from 1999 to 2004. There are approximately 1.0 - 1.2 million persons estimated to be living with HIV of whom 25% are unaware of their infection and likely to have transmitted their infection unknowingly. Despite considerable survival benefits if treatment is initiated early before symptoms develop 40% of patients receive their HIV diagnosis less than 12 months before developing AIDS. Early HIV diagnosis may therefore be of both public health and individual survival benefit. On 22 September 2006 the United States National Center for HIV/ AIDS published revised recommendations for HIV testing of adults adolescents and pregnant women to facilitate HIV testing as a normal part of medical practice similar to screening for other treatable conditions. HIV screening for all patients in US health care settings is now recommended unless the patient declines (i.e. opt-out screening). Separate written consent for HIV testing is no longer required and general consent for medical care will be considered sufficient to encompass consent for HIV testing. Prevention counselling will not be required with HIV diagnostic testing or as part of HIV screening programmes in health care settings. The objective of the revised policy is to increase HIV screening of patients and pregnant women in health care settings to foster earlier detection of HIV infection identify and counsel individuals with unrecognised HIV infection and link them to clinical and prevention services. (excerpt)