Vital Signs: Hepatitis C Treatment Among Insured Adults - United States, 2019-2020.

INTRODUCTION: Over 2 million adults in the United States have hepatitis C virus (HCV) infection, and it contributes to approximately 14,000 deaths a year. Eight to 12 weeks of highly effective direct-acting antiviral (DAA) treatment, which can cure ≥95% of cases, is recommended for persons with hepatitis C. METHODS: Data from HealthVerity, an administrative claims and encounters database, were used to construct a cohort of adults aged 18-69 years with HCV infection diagnosed during January 30, 2019-October 31, 2020, who were continuously enrolled in insurance for ≥60 days before and ≥360 days after diagnosis (47,687). Multivariable logistic regression was used to assess the association between initiation of DAA treatment and sex, age, race, payor, and Medicaid restriction status; adjusted odds ratios (aORs) and 95% CIs were calculated. RESULTS: The prevalence of DAA treatment initiation within 360 days of the first positive HCV RNA test result among Medicaid, Medicare, and private insurance recipients was 23%, 28%, and 35%, respectively; among those treated, 75%, 77%, and 84%, respectively, initiated treatment within 180 days of diagnosis. Adjusted odds of treatment initiation were lower among those with Medicaid (aOR = 0.54; 95% CI = 0.51-0.57) and Medicare (aOR = 0.62; 95% CI = 0.56-0.68) than among those with private insurance. After adjusting for insurance type, treatment initiation was lowest among adults aged 18-29 and 30-39 years with Medicaid or private insurance, compared with those aged 50-59 years. Among Medicaid recipients, lower odds of treatment initiation were found among persons in states with Medicaid treatment restrictions (aOR = 0.77; 95% CI = 0.74-0.81) than among those in states without restrictions, and among persons whose race was coded as Black or African American (Black) (aOR = 0.93; 95% CI = 0.88-0.99) or other race (aOR = 0.73; 95% CI = 0.62-0.88) than those whose race was coded as White. CONCLUSIONS AND IMPLICATIONS FOR PUBLIC HEALTH PRACTICE: Few insured persons with diagnosed hepatitis C receive timely DAA treatment, and disparities in treatment exist. Unrestricted access to timely DAA treatment is critical to reducing viral hepatitis-related mortality, disparities, and transmission. Treatment saves lives, prevents transmission, and is cost saving.

Assessment of Phenobarbital Administration to Reduce Opioid and Benzodiazepine Use in the Immediate Postoperative Period Following Stage 2 Single-Ventricle Palliation.

OBJECTIVE: The Glenn procedure may lead to the development of elevated cerebral venous pressures, which is believed to result in "Glenn headaches." This manifests as excessive irritability, often requiring significant use of opioids and benzodiazepines. This study was designed to report our experience with the use of phenobarbital in the postoperative phase after the Glenn procedure. METHODS: We performed a retrospective chart review to compare Glenn patients before and after implementation of a sedation protocol using phenobarbital. The 2 groups were compared for demographics, surgical characteristics, and cumulative sedation usage. Correlation coefficients between the preoperative catheterization variables and sedation usage were also calculated. RESULTS: Groups A (pre-phenobarbital; n = 8) and B (post-phenobarbital; n = 11) were comparable in terms of demographics, cardiac anatomy, preoperative catheterization data, and hemodynamics. Patients in Group B received a median dose of 21.8 mg/kg of phenobarbital during their ICU stay. Although there was a decreased administration of morphine equivalents (2.60 mg/kg vs 2.25 mg/kg, p = 0.38), benzodiazepine (0.1 mg/kg vs 0.074 mg/kg, p = 0.43), and dexmedetomidine (47 mcg/kg vs 37.2 mcg/kg, p = 0.53) in Group B, the differences were not statistically significant. There was also no strong correlation between preoperative hemodynamic variables and the postoperative sedation requirement, and there was no statistically significant difference in overall outcomes between the 2 groups. CONCLUSIONS: While phenobarbital may have mitigated the use of opioids, benzodiazepines, and alpha-agonist agents in some postoperative Glenn patients, the overall findings for all patients were not statistically significant. Further prospective studies are needed to ascertain the role of phenobarbital in these patients.

Willingness to Receive a COVID-19 Vaccination Among Incarcerated or Detained Persons in Correctional and Detention Facilities - Four States, September-December 2020.

Incarcerated and detained persons are at increased risk for acquiring COVID-19. However, little is known about their willingness to receive a COVID-19 vaccination. During September-December 2020, residents in three prisons and 13 jails in four states were surveyed regarding their willingness to receive a COVID-19 vaccination and their reasons for COVID-19 vaccination hesitancy or refusal. Among 5,110 participants, 2,294 (44.9%) said they would receive a COVID-19 vaccination, 498 (9.8%) said they would hesitate to receive it, and 2,318 (45.4%) said they would refuse to receive it. Willingness to receive a COVID-19 vaccination was lowest among Black/African American (Black) (36.7%; 510 of 1,390) persons, participants aged 18-29 years (38.5%; 583 of 1,516), and those who lived in jails versus prisons (43.7%; 1,850 of 4,232). Common reasons reported for COVID-19 vaccine hesitancy were waiting for more information (54.8%) and efficacy or safety concerns (31.0%). The most common reason for COVID-19 vaccination refusal was distrust of health care, correctional, or government personnel or institutions (20.1%). Public health interventions to improve vaccine confidence and trust are needed to increase vaccination acceptance by incarcerated or detained persons.

Evaluation of wait times for patients seeking cosmetic and reconstructive breast surgery.

BACKGROUND: Patients seeking cosmetic or reconstructive procedures in plastic surgery typically face significant wait times for consultations. Little attention has been given to potential disparities in wait times between elective cosmetic and reconstructive procedures. In this initial pilot study, we audited a broad sample of plastic surgery offices within a single state for wait times in initial consultations for both breast reconstruction and breast augmentation. METHODS: A sample of board-certified plastic surgeons was audited from the American Society of Plastic Surgeons (ASPS) Web site that listed both cosmetic and reconstructive breast surgery. Scripted patient telephone calls were made to 67 plastic surgery clinics within a single state on May 2012. Two calls separated by 7 days were made to each office by the same actor seeking an initial appointment for either breast reconstruction or breast augmentation. Wait times were calculated from the date of the call until the date of appointment offered. RESULTS: There were 72 paired calls completed on 36 plastic surgery clinics. Significant disparities in appointment wait times existed between elective cosmetic versus reconstructive procedures (P = 0.02). Mean wait times for breast reconstruction consultation (26.1 days) were significantly longer than mean consultation wait times for breast augmentation (20.9 days). Interestingly, 17.9% of offices contacted no longer perform certain procedures currently advertised on the ASPS Web site. CONCLUSIONS: Disparities exist in access to care between patients seeking elective breast augmentation and reconstruction after mastectomy. Patients seeking breast augmentation have more rapid access to plastic surgeons. This study did not evaluate possible explanations for the observed differences. Potential causes may include physician preference and compensation benefits for cosmetic procedures.

Assessment of pain as a sequela in patients treated with intracavitary brachytherapy accelerated partial breast irradiation (IBAPBI): preliminary results of a prospective study.

To assess pain rates and relationship to radiation-induced fibrosis (RIF) in patients treated with intracavitary brachytherapy accelerated partial breast irradiation (IBAPBI). Thirty-nine patients treated with IBAPBI were assessed prospectively for development of pain pretreatment, 1 month post-IBAPBI, and every 6 months thereafter. A qualitative subjective Late Effects of Normal Tissue-Subjective Objective Management Analytical (LENT-SOMA) questionnaire assessed pain. Use of pain medications was assessed as "no", "sometimes", or "regularly". A quantitative objective validated pressure threshold (PTH) measured pain in the site of IBAPBI breast (index) and its mirror-image in the nonirradiated breast (control). A validated tissue compliance meter (TCM) quantitatively assessed RIF in the index and control breasts at all time points. Mean ΔPTH(kg) and ΔTCM(mm) values reflected mean difference between the index and control breasts. Median follow-up is 44 months (range 5-59 months). According to LENT-SOMA, pain occurred in 89% at 1 and 24 months, 67% at 30 months, 30% at 36 months, 29% at 40 months, and 20% at 48 months. No patient used pain medication "regularly" but the use "sometimes" decreased over time: 61% at 1 month, 42% at 18 and 24 months, 13% at 36 months, and 10% at 40 months. Mean ΔPTH values, compared to Δ0 kg at baseline, peaked in absolute value by 1 month to -1.36 kg (p < 0.0001), persisted after 18 months at -0.99 kg (p < 0.0001) and 24 months at -0.73 kg (p < 0.0001), and returned to nearly baseline by 40 months at -0.11 kg (p < 0.57). Mean ΔPTH and ΔTCM correlated significantly with subjective patient reports of pain at each time point (p < 0.0001). To date, this is the first report to prospectively assess pain employing quantitative and qualitative inventories in patients treated with IBAPBI. Pain is experienced in the majority of patients experienced pain within the first 2 years, sometimes requiring a medication, and though subsides, it may persist 4 years after IBAPBI.

Assessment of management policies and practices for occupational exposure to bloodborne pathogens in dialysis facilities.

BACKGROUND: Occupational exposure management is an important element in preventing the transmission of bloodborne pathogens in health care settings. In 2008, the US Centers for Disease Control and Prevention conducted a survey to assess procedures for managing occupational bloodborne pathogen exposures in outpatient dialysis facilities in the United States. STUDY DESIGN: A cross-sectional survey of randomly selected outpatient dialysis facilities. SETTING & PARTICIPANTS: 339 outpatient dialysis facilities drawn from the 2006 US end-stage renal disease database. PREDICTORS: Hospital affiliation (free-standing vs hospital-based facilities), profit status (for-profit vs not-for-profit facilities), and number of health care personnel (≥100 vs <100 health care personnel). OUTCOMES: Exposures to hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV); provision of HBV and HIV postexposure prophylaxis. MEASUREMENTS: We calculated the proportion of facilities reporting occupational bloodborne pathogen exposures and offering occupational exposure management services. We analyzed bloodborne pathogen exposures and provision of postexposure prophylaxis by facility type. RESULTS: Nearly all respondents (99.7%) had written policies and 95% provided occupational exposure management services to health care personnel during the daytime on weekdays, but services were provided infrequently during other periods of the week. Approximately 10%-15% of facilities reported having HIV, HBV, or HCV exposures in health care personnel in the 12 months prior to the survey, but inconsistencies were noted in procedures for managing such exposures. Despite 86% of facilities providing HIV prophylaxis for exposed health care personnel, only 37% designated a primary HIV postexposure prophylaxis regimen. For-profit and free-standing facilities reported fewer exposures, but did not as reliably offer HBV prophylaxis or have a primary HIV postexposure prophylaxis regimen relative to not-for-profit and hospital-based facilities. LIMITATIONS: The survey response rate was low (37%) and familiarity of individuals completing the survey with facility policies or national guidelines could not be ascertained. CONCLUSIONS: Significant improvements are required in the implementation of guidelines for managing occupational exposures to bloodborne pathogens in outpatient dialysis facilities.

Bone flap perfusion assessment using near-infrared fluorescence imaging.

BACKGROUND: Microsurgical vascularized bone flaps are a versatile technique for reconstructing large bone defects. However, the assessment of perfusion is challenging, because clinical examination is difficult intraoperatively and often not possible postoperatively. Therefore, it is important to develop techniques to assess the perfusion of vascularized bone flaps and potentially improve the surgical outcomes. Near-infrared (NIR) fluorescence imaging has previously been shown to provide real-time, intraoperative evaluation of vascular perfusion. The present pilot study investigated the ability of NIR imaging to assess the perfusion of vascularized bone flaps. METHODS: Vascularized bone flaps were created in female Yorkshire pigs using well-established models for porcine forelimb osteomyocutaneous flap allotransplantation (n = 8) and hindlimb fibula flaps (n = 8). Imaging of the bone flaps was performed during harvest using the FLARE intraoperative fluorescence imaging system after systemic injection of indocyanine green. Perfusion was also assessed using the standard of care by clinical observation and Doppler ultrasonography. NIR fluorescence perfusion assessment was confirmed by intermittent clamping of the vascular pedicle. RESULTS: NIR fluorescence imaging could identify bone perfusion at the cut end of the osteotomy site. When the vascular pedicle was clamped or ligated, NIR imaging demonstrated no fluorescence when injected with indocyanine green. With clamp removal, the osteotomy site emitted fluorescence, indicating bone perfusion. The results using fluorescence imaging showed 100% agreement with the clinical observation and Doppler findings. CONCLUSIONS: Vascularized bone transfers have become an important tool in reconstructive surgery; however, no established techniques are available to adequately assess perfusion. The results of our pilot study have indicated that NIR imaging can provide real-time, intraoperative assessment of bone perfusion.

Vascular access hemorrhages contribute to deaths among hemodialysis patients.

In 2007 the Maryland Medical Examiner noted a potential cluster of fatal vascular access hemorrhages among hemodialysis patients, many of whom died outside of a health-care setting. To examine the epidemiology of fatal vascular access hemorrhages, we conducted a retrospective case review in District of Columbia, Maryland, and Virginia from January 2000 to July 2007 and a case-control study. Records from the Medical Examiner and Centers for Medicare and Medicaid Services were reviewed, from which 88 patients were identified as fatal vascular access hemorrhage cases. To assess risk factors, a subset of 20 cases from Maryland was compared to 38 controls randomly selected among hemodialysis patients who died from non-vascular access hemorrhage causes at the same Maryland facilities. Of the 88 confirmed cases, 55% hemorrhaged from arteriovenous grafts, 24% from arteriovenous fistulas, and 21% from central venous catheters. Of 82 case-patients with known location of hemorrhage, 78% occurred at home or in a nursing home. In the case-control analysis, statistically significant risk factors included the presence of an arteriovenous graft, access-related complications within 6 months of death, and hypertension; presence of a central venous catheter was significantly protective. Psychosocial factors and anticoagulant medications were not significant risk factors. Effective strategies to control vascular access hemorrhage in the home and further delineation of warning signs are needed.

Face transplant perfusion assessment using near-infrared fluorescence imaging.

BACKGROUND: Composite tissue allografts (CTAs) including partial face transplantation have been achieved clinically. However, risks of complications including tissue ischemia, rejection, and transplant failure are significant. Safe and effective techniques to assess perfusion are needed to decrease complications in composite tissue flaps. Near-infrared (NIR) fluorescence imaging has been previously shown to provide a real-time, intraoperative evaluation of perfusion. This study investigates the use of NIR imaging in partial face CTA harvest. METHODS: We created hemifacial CTAs (n = 8) using an established porcine model. This included ear cartilage, nerve, lymphoid tissue, muscle, and skin with perfusion by the carotid artery and external jugular vein. We injected animals systemically with indocyanine green and obtained NIR fluorescence images simultaneously with color video. In addition, we assessed the elevated hemifacial flaps using standard of care (i.e., clinical examination and Doppler). RESULTS: Flap design was facilitated by NIR imaging with localization of perforators to the hemifacial CTA flap. In particular, an arterial and venous phase could be clearly identified. We assessed perfusion of the flap by NIR fluorescence intensity after injection of indocyanine green. Sequential clamping of the artery and vein confirmed correlation of perfusion deficits with NIR imaging as well as with clinical examination and Doppler. CONCLUSIONS: Evaluation and assessment of perfusion are important in facial transplantation. The results from our pilot study indicate that NIR imaging has the capability to assess perfusion of partial facial CTAs. This emergent technology shows promise in assessing tissue perfusion in a composite flap.

Determining the gluten content of nonprescription drugs: information for patients with celiac disease.

OBJECTIVES: To determine whether the information on the gluten content of nonprescription drugs is readily available from the manufacturer/supplier, to identify how patients are directed on the product labeling to obtain answers to questions that they have about the nonprescription medication, and to determine the time needed to obtain information about the gluten content of the product when contacting manufacturers/suppliers. DESIGN: Descriptive, exploratory, nonexperimental study. SETTING: United States during July 2010. PARTICIPANTS: Manufacturers/suppliers of 41 nonprescription drug products. INTERVENTION: The packaging of the products was reviewed for information on gluten content. The manufacturer/supplier listed on each product's packaging was contacted using the phone number provided and questioned about the gluten content of the product. A uniform script was used for the telephone inquiry. The responses provided and the duration of the phone calls were documented. The manufacturer's websites also were reviewed for pertinent information. MAIN OUTCOME MEASURES: Gluten status of products, time spent on phone to determine gluten status, and availability of online information regarding gluten status. RESULTS: Information concerning the gluten content was not included on any of the products' packaging. The mean time required to receive a response was 6.2 minutes (median 5 minutes). A total of 15 products were reported to be gluten free; 13 products were not tested, but the manufacturer/supplier stated that they did not add gluten to the products; 9 products did not have any gluten added by the manufacturer/ supplier, but no guarantee was made that the raw ingredients were gluten free; 2 products contained gluten; and 2 products had no available gluten status information. Gluten information was found on product websites for a total of six products. Four of those six websites indicated gluten status that was different from the information provided via the telephone call with the manufacturer. CONCLUSION: Information concerning the gluten content of many nonprescription drugs is relatively easy for patients to obtain if the manufacturer/supplier is contacted. Although the time to obtain a response was quite short for many of the inquiries, it took a substantial amount of time to receive the requested information from some of the companies.

Infection control assessment of ambulatory surgical centers.

CONTEXT: More than 5000 ambulatory surgical centers (ASCs) in the United States participate in the Medicare program. Little is known about infection control practices in ASCs. The Centers for Medicare & Medicaid Services (CMS) piloted an infection control audit tool in a sample of ASC inspections to assess facility adherence to recommended practices. OBJECTIVE: To describe infection control practices in a sample of ASCs. DESIGN, SETTING, AND PARTICIPANTS: All State Survey Agencies were invited to participate. Seven states volunteered; 3 were selected based on geographic dispersion, number of ASCs each state committed to inspect, and relative cost per inspection. A stratified random sample of ASCs was selected from each state. Sample size was based on the number of inspections each state estimated it could complete between June and October 2008. Sixty-eight ASCs were assessed; 32 in Maryland, 16 in North Carolina, and 20 in Oklahoma. Surveyors from CMS, trained in use of the audit tool, assessed compliance with specific infection control practices. Assessments focused on 5 areas of infection control: hand hygiene, injection safety and medication handling, equipment reprocessing, environmental cleaning, and handling of blood glucose monitoring equipment. MAIN OUTCOME MEASURES: Proportion of facilities with lapses in each infection control category. RESULTS: Overall, 46 of 68 ASCs (67.6%; 95% confidence interval [CI], 55.9%-77.9%) had at least 1 lapse in infection control; 12 of 68 ASCs (17.6%; 95% CI, 9.9%-28.1%) had lapses identified in 3 or more of the 5 infection control categories. Common lapses included using single-dose medication vials for more than 1 patient (18/64; 28.1%; 95% CI, 18.2%-40.0%), failing to adhere to recommended practices regarding reprocessing of equipment (19/67; 28.4%; 95% CI, 18.6%-40.0%), and lapses in handling of blood glucose monitoring equipment (25/54; 46.3%; 95% CI, 33.4%-59.6%). CONCLUSION: Among a sample of US ASCs in 3 states, lapses in infection control were common.

Telavancin: a novel lipoglycopeptide antibiotic.

OBJECTIVE: To review the pharmacology, antimicrobial activity, pharmacokinetics, clinical applications, and safety of telavancin, a new lipoglycopeptide antibiotic. DATA SOURCES: Literature was obtained from MEDLINE (1966-April 2009) and International Pharmaceutical Abstracts (1971-April 2009) using the search terms telavancin and TD-6424, and also from Theravance, Inc., and Astellas Pharma US, Inc. STUDY SELECTION AND DATA EXTRACTION: Available English-language articles were reviewed, as well as information obtained from Theravance, Inc., and Astellas Pharma US, Inc. DATA SYNTHESIS: Telavancin has rapid bactericidal activity against gram-positive aerobic and anaerobic bacteria through multiple mechanisms of action. In vitro and Phase 2 in vivo data support the efficacy of telavancin against antibiotic-resistant gram-positive organisms. On March 4, 2008, the Food and Drug Administration (FDA) accepted as complete for review Theravance's response to the October 19, 2007, New Drug Application approvable letter for telavancin to be used as treatment for complicated skin and skin structure infections (cSSSIs) caused by gram-positive bacteria. QTc interval prolongation has been reported, although the clinical impact of this has not been determined. Drug interactions have not been identified as of yet. CONCLUSIONS: Telavancin is currently under review by the FDA for the treatment of cSSSIs caused by gram-positive bacteria. The completion of Phase 3 trials will determine whether telavancin will have a role in the treatment of other infections caused by resistant gram-positive bacteria.