Neuroticism as a moderator of symptom-related distress and depression in 4 noncancer end-of-life populations.

OBJECTIVES: Neuroticism is a significant predictor of adverse psychological outcomes in patients with cancer. Less is known about how this relationship manifests in those with noncancer illness at the end-of-life (EOL). The objective of this study was to examine the impact of neuroticism as a moderator of physical symptoms and development of depression in patients with amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), end-stage renal disease (ESRD), and frailty in the last 6 months of life. METHODS: We met this objective using secondary data collected in the Dignity and Distress across End-of-Life Populations study. The data included N = 404 patients with ALS (N = 101), COPD (N = 100), ESRD (N = 101), and frailty (N = 102) in the estimated last 6 months of life, with a range of illness-related symptoms, assessed longitudinally at 2 time points. We examined neuroticism as a moderator of illness-related symptoms at Time 1 (∼6 months before death) and depression at Time 2 (∼3 months before death) using ordinary least squares regression. RESULTS: Results revealed that neuroticism significantly moderated the relationship between the following symptoms and depression measured 3 months later: drowsiness, fatigue, shortness of breath, wellbeing (ALS); drowsiness, trouble sleeping, will to live, activity (COPD); constipation (ESRD); and weakness and will to live (frailty). SIGNIFICANCE OF RESULTS: These findings suggest that neuroticism represents a vulnerability factor that either attenuates or amplifies the relationship of specific illness and depressive symptoms in these noncancer illness groups at the EOL. Identifying those high in neuroticism may provide insight into patient populations that require special care at the EOL.

A Longitudinal Study of Correlates, Discharge Disposition, and Rate of Re-presentation to Emergency Services of Adults who Engage in Non-suicidal Self-injury.

OBJECTIVE: In DSM-5, non-suicidal self-injury (NSSI) and suicide attempts (SA) are classified as distinct disorders in the section of conditions for further study. However, some have questioned the validity of distinguishing NSSI from SA. The objective of this study was to longitudinally examine the correlates, discharge disposition, and rate of re-presentation to emergency services of adults who engaged in NSSI and compare them to (a) adults who engage in SA and (b) adults with no self-harm or suicidal ideation (SI). METHOD: Data came from 4,772 presentations to adult psychiatric services in the emergency departments of tertiary care hospitals in Winnipeg, Canada between January 2009 and June 2012. Chart reviews were conducted for all presentations with NSSI (n = 158), and a sample of those with SA (n = 172) and no SH or SI (n = 173). RESULTS: Among the adults who returned to emergency services, those who originally presented with SA re-presented significantly sooner than those who presented with NSSI. (χ2(1) = 7.457, p = 0.006). Those who originally presented with NSSI that returned to hospital did not return with repeat NSSI, but instead the majority re-presented with suicidal thoughts and SA. Further, those who re-presented with NSSI and SA were less likely to be hospitalized or to receive a referral to mental health services, and more likely to be discharged to usual care at time of initial presentation. CONCLUSIONS: Overall, these findings indicate a trajectory of escalation of self-harm behavior for certain people who engage in NSSI, especially those who re-present to emergency services.HIGHLIGHTSA quarter of people with self-harm re-present to emergency services within four-and-a-half years.Those with suicide attempts re-presented significantly sooner than non-suicidal self-injury.There is a need for increased interventions in emergency services for those with self-harm.

Longitudinal Mixed Modelling of Emergency Department Use Among a Sample of Homeless Participants in a Housing First Demonstration Trial.

The present Canadian study sought to identify predictors of emergency department (ED) use in a sample of adults who are homeless. Four hundred eighty-three participants were interviewed quarterly for two years, reporting their housing status, income, food security, physical/mental health, and other social determinants of health. Survey data were linked to administrative health and social services data. Predictors of ED visits were analyzed using negative binomial longitudinal mixed modelling. Emergency department visits were positively and reliably predicted by pre-baseline ED use, as well as by concurrent increased social assistance, primary care visits, ratings of physical health, substance use problems, and case management visits. Increased concurrent housing instability and food insecurity, and decreased homelessness history, positively predicted ED visits, but effect reliability was lower. Participant ill health appears to be a primary driver of ED utilization. The findings challenge misconceptions about the appropriateness of ED use among people who are homeless.

Identification of variants associated with hard clam, Mercenaria mercenaria, resistance to Quahog Parasite Unknown disease.

Severe losses in aquacultured and wild hard clam (Mercenaria mercenaria) stocks have been previously reported in the northeastern United States due to a protistan parasite called QPX (Quahog Parasite Unknown). Previous work demonstrated that clam resistance to QPX is under genetic control. This study identifies single nucleotide polymorphism (SNP) associated with clam survivorship from two geographically segregated populations, both deployed in an enzootic site. The analysis contrasted samples collected before and after undergoing QPX-related mortalities and relied on a robust draft clam genome assembly. ~200 genes displayed significant variant enrichment at each sampling point in both populations, including 18 genes shared between both populations. Markers from both populations were identified in genes related to apoptosis pathways, protein-protein interaction, receptors, and signaling. This research begins to identify genetic markers associated with clam resistance to QPX disease, leading the way for the development of resistant clam stocks through marker-assisted selection.

A Comparison of Self-Harm Presentations to Emergency Services.

Background: In the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, the distinction between nonsuicidal self-injury (NSSI) and suicide attempts (SA) is highlighted in the section of conditions for further study. Aims: The objective of this study was to examine the correlates of people who presented to emergency departments (ED) with NSSI compared with those who presented with SA and no self-harm or suicidal ideation (no SH or SI). Method: Data came from 4,772 presentations to ED of tertiary care hospitals in Manitoba, Canada, between January 2009 and June 2012. Chart reviews were conducted for presentations with NSSI (n = 158), and a sample of SA (n = 172) and no SH or SI (n = 173). Results: NSSI was associated with borderline personality traits/disorders, previous history of SH, and aggression/impulsivity compared with no SH or SI. SA was associated with a lower likelihood of adjustment disorder (OR = 0.58; 95 % CI [0.34, 0.99]) and previous history of NSSI (OR = 0.30; 95 % CI [0.17, 0.53]) compared with NSSI. Limitations: A limitation of this study is its cross-sectional design. Conclusion: Given the distress associated with NSSI, the findings highlight the need for treatment plans that address all those who present to ED with SH regardless of intent.

Fixed Nodes of Transience: Narratives of Homelessness and Emergency Department Use.

Discourse in popular media, public policy, and academic literature contends that people who are homeless frequently make inappropriate use of hospital emergency department (ED) services. Although researchers have investigated the ED experiences of people who are homeless, no previous studies have examined how this population understands the role of the ED in their health care and in their day-to-day lives. In the present study, 16 individuals participated in semistructured interviews regarding their ED experiences, and narrative analysis was applied to their responses. Within the context of narratives of disempowerment and discrimination, participants viewed the ED in differing ways, but they generally interpreted it as a public, accessible space where they could exert agency. ED narratives were also paradoxical, depicting it as a fixed place for transient care, or a place where they were isolated yet felt a sense of belonging. Implications for policy and practice are discussed.

Safety and Effectiveness of VYC-17.5L for Long-Term Correction of Nasolabial Folds.

BACKGROUND: Juvéderm Vollure XC (VYC-17.5L; Allergan plc, Dublin, Ireland) belongs to a family of hyaluronic acid gels based on the Vycross technology platform. OBJECTIVES: The authors sought to evaluate the safety and effectiveness of Vollure for correction of moderate to severe nasolabial folds (NLFs) over 18 months and after repeat treatment. METHODS: In this prospective, randomized study, patients (N = 123) received initial/touch-up treatment with Vollure in 1 NLF and control filler in the contralateral NLF. Patients received optional repeat treatment with Vollure after month 12, 15, or 18. Assessments included investigator-rated NLF Severity Scale responder rates (≥1-point improvement vs baseline), patient-assessed Appraisal of Nasolabial Folds scale of the FACE-Q questionnaire, and patient satisfaction (11-point scale). RESULTS: Median volume of Vollure injected was 1.7 mL for initial/touch-up treatment combined and 0.6 mL for repeat treatment. The NLF Severity Scale responder rates were 93%, 85%, and 59% at months 6, 9, and 18 after initial/touch-up treatment and increased to 94% at 1 month after repeat treatment. Mean patient-reported FACE-Q scores significantly improved from baseline at all timepoints. Most patients were very satisfied with treatment at all timepoints from day 3 (75%) through month 18 (68%) and at 1 month after repeat treatment (94%). Common injection site responses after initial/touch-up and repeat treatment were firmness, swelling, and tenderness to touch; most were mild/moderate. CONCLUSIONS: Vollure was safe and effective for correction of moderate to severe NLFs, with results lasting 18 months in 59% of NLFs. Repeat treatment required one-third of the injection volume to achieve similar improvement in NLF severity as initial/touch-up treatment.

Safety and Effectiveness of Repeat Treatment With VYC-15L for Lip and Perioral Enhancement: Results From a Prospective Multicenter Study.

BACKGROUND: VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine. OBJECTIVES: To evaluate safety and effectiveness of repeat treatment with VYC-15L administered 1 year after treatment for lip and perioral enhancement. METHODS: In this prospective multicenter study, 124 subjects with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) who received initial/touch-up treatment with VYC-15L received repeat treatment with VYC-15L 1 year after initial treatment. Effectiveness endpoints included LFS responder rates (≥1-point improvement from baseline) and scores on the FACE-Q Satisfaction With Lips and Appraisal of Lip Lines scales at 1 month after repeat treatment. Subjects completed safety diaries for 30 days after repeat treatment. RESULTS: LFS responder rates were 86.2%, 80.3%, and 65.3% at months 1 and 3 and 1 year, respectively, after initial/touch-up treatment. The responder rate improved to 94.3% 1 month after repeat treatment with VYC-15L and required less median volume vs initial/touch-up treatment (1.5 vs 2.6 mL). FACE-Q scores doubled from baseline at 3 months, remained high through 1 year, and doubled from baseline after repeat treatment. At 1 month after repeat treatment, 96.7% and 89.3% of subjects showed improvement over baseline in FACE-Q Satisfaction With Lips and Appraisal of Lip Lines, respectively. Severe injection site responses were less frequent after repeat treatment than initial/touch-up treatment. CONCLUSIONS: Repeat treatment with VYC-15L at 1 year was safe and effective for lip and perioral enhancement, and required less product volume to achieve similar effectiveness to initial/touch-up treatment.

Lactation Outcomes in More Than 3500 Women Following Primary Augmentation: 5-Year Data From the Breast Implant Follow-Up Study.

BACKGROUND: Women with breast implants may have concerns about their ability to successfully breast-feed. The Breast Implant Follow-up Study (BIFS-001) is a large, 10-year observational study evaluating the performance and safety of Natrelle round silicone gel-filled breast implants. OBJECTIVES: This analysis compared lactation outcomes in women enrolled in BIFS-001 who gave birth after they underwent primary augmentation with Natrelle round silicone implants or saline implants. METHODS: At baseline and annually after surgery (>5-year visit window), patients completed questionnaires regarding pregnancy and lactation. Comparisons were made using summary statistics and odds ratios with 90% confidence intervals (OR [90% CI]). RESULTS: A total of 4679 subjects gave birth at least once after primary augmentation for a total of 5736 live births during the study (silicone, 3695 births; saline, 2041 births). Of these, 3715 (79.4%) women breast-fed at least 1 child, resulting in 80.0% (silicone) and 75.9% (saline) of babies being breast-fed. The most common complication was insufficient milk production, which was reported for 19.6% (silicone) and 19.8% (saline) of single births (OR, 0.94 [0.83, 1.06]). Complications occurred at similar rates in each group when evaluated by incision type, implant size, pocket location, and age. CONCLUSIONS: In this large group of women who gave birth after primary breast augmentation with Natrelle round silicone implants or saline implants, most were able to breast-feed their infants without complications. Lactation complications were comparable between the silicone and saline cohorts, and the incidence was comparable to reports in the general population of women who breast-feed.

An innovative approach to educating nurses to clinical competence: A randomized controlled trial.

AIM: This study examined the effect of mastery learning on new graduate nurses' skill and self-regulation practices for indwelling urinary catheter insertion in a simulated learning environment. BACKGROUND: Clinical competence is a patient safety imperative, it is therefore important to use the most effective approaches to prepare competent nurses resulting in improved patient care and clinical outcomes. Catheter associated Urinary Tract Infections (CaUTI) are a nursing quality indicator, and account for 30% of all Hospital-Acquired Conditions (HAC) annually in the US. DESIGN: A longitudinal randomized control trial to compare two learning groups. SETTING: Large acute care health system. PARTICIPANTS: 40 Nurses with a Bachelor of Science Degree in Nursing (BSN) and who were new graduate nurses. METHOD: Participants were randomized into the experimental group (mastery learning) or the control group (traditional learning). Both groups were asked to complete a self-paced computerized instructional module that reviewed the procedural steps for the insertion of an indwelling urinary catheter in a female prior to the initial assessment. This study examined performance of insertion of a urinary catheter initially and at one-month post intervention and the self-regulation practices of all participants. RESULTS: The mean Survey of Academic Self-Regulation (SASR) scores between groups was significant, p = .035. The mean change in the Performance Assessment Tool (PAT) 17-critical steps scores between groups was also significant, p = .013. CONCLUSION: Retention of the critical steps is valuable because if performed incorrectly, these steps may cause harm to the patient. Self-regulation practices promote confidence and an intrinsic motivation to ask for help when clinical practice questions arise.

Performance of intraclass correlation coefficient (ICC) as a reliability index under various distributions in scale reliability studies.

Many published scale validation studies determine inter-rater reliability using the intra-class correlation coefficient (ICC). However, the use of this statistic must consider its advantages, limitations, and applicability. This paper evaluates how interaction of subject distribution, sample size, and levels of rater disagreement affects ICC and provides an approach for obtaining relevant ICC estimates under suboptimal conditions. Simulation results suggest that for a fixed number of subjects, ICC from the convex distribution is smaller than ICC for the uniform distribution, which in turn is smaller than ICC for the concave distribution. The variance component estimates also show that the dissimilarity of ICC among distributions is attributed to the study design (ie, distribution of subjects) component of subject variability and not the scale quality component of rater error variability. The dependency of ICC on the distribution of subjects makes it difficult to compare results across reliability studies. Hence, it is proposed that reliability studies should be designed using a uniform distribution of subjects because of the standardization it provides for representing objective disagreement. In the absence of uniform distribution, a sampling method is proposed to reduce the non-uniformity. In addition, as expected, high levels of disagreement result in low ICC, and when the type of distribution is fixed, any increase in the number of subjects beyond a moderately large specification such as n = 80 does not have a major impact on ICC.

Safety and Effectiveness of the Hyaluronic Acid Dermal Filler VYC-17.5L for Nasolabial Folds: Results of a Randomized, Controlled Study.

BACKGROUND: Juvéderm Vollure XC (VYC-17.5L) belongs to a family of nonanimal hyaluronic acid (HA) gels based on the Vycross technology platform. OBJECTIVE: To evaluate the safety and effectiveness of VYC-17.5L for correction of moderate to severe nasolabial folds (NLFs) compared with a control HA dermal filler. METHODS: In this double-blind study, 123 adults with 2 moderate or severe NLFs as measured on the 5-point photonumeric NLF severity scale (NLFSS) were randomized to VYC-17.5L in 1 NLF and control in the contralateral NLF. The coprimary effectiveness end points at Month 6 were difference in improvement in mean NLFSS score for VYC-17.5L versus control and NLFSS responder rate (≥1-point improvement) for VYC-17.5L. RESULTS: The coprimary effectiveness end points were met. NLFSS scores improved by 1.4 with VYC-17.5L and by 1.3 with control; NLFSS responder rate with VYC-17.5L was 93.2%. More than three-quarters of subjects (82%) treated with VYC-17.5L were very satisfied at Month 6. Investigators reported that VYC-17.5L was smoother and more natural looking and easier to inject and mold than control. VYC-17.5L resulted in significantly fewer severe injection site responses than control. CONCLUSION: VYC-17.5L was safe and effective for correcting moderate to severe NLFs, with results lasting through 6 months in 93% of subjects.

Negotiating home base: Narratives of psychological well-being among female military members.

The current study aimed to understand how active duty service women with low levels of current psychological distress make sense of their military experiences in ways that might contribute to psychological well-being. Semi-structured interviews were conducted with active duty female members in the Canadian Forces and transcripts were analyzed using narrative analysis. A sense of belonging was found to be of utmost salience to the women, with several participants negotiating and constructing places that felt like home to them, and with different degrees of attachment to the military versus civilian world. The findings of this work are discussed within the context of focusing prevention and intervention efforts on increasing belongingness and a sense of home for female service members.

Five-Year Safety Data for More than 55,000 Subjects following Breast Implantation: Comparison of Rare Adverse Event Rates with Silicone Implants versus National Norms and Saline Implants.

BACKGROUND: The U.S. Food and Drug Administration has required postapproval studies of silicone breast implants to evaluate the incidence of rare adverse events over 10 years after implantation. METHODS: The Breast Implant Follow-Up Study is a large 10-year study (>1000 U.S. sites) evaluating long-term safety following primary augmentation, revision-augmentation, primary reconstruction, or revision-reconstruction with Natrelle round silicone breast implants compared with national norms and outcomes with saline implants. Targeted adverse events in subjects followed for 5 to 8 years included connective tissue diseases, neurologic diseases, cancer, and suicide. RESULTS: The safety population comprised 55,279 women (primary augmentation, n = 42,873; revision-augmentation, n = 6837; primary reconstruction, n = 4828; and revision-reconstruction, n = 741). No targeted adverse events occurred at significantly greater rates in silicone implant groups versus national norms across all indications. The standardized incidence rate (observed/national norm) for all indications combined was 1.4 for cervical/vulvar cancer, 0.8 for brain cancer, 0.3 for multiple sclerosis, and 0.1 for lupus/lupus-like syndrome. Silicone implants did not significantly increase the risk for any targeted adverse events compared with saline implants. The risk of death was similar with silicone versus saline implants across all indications. The suicide rate (10.6 events per 100,000 person-years) was not significantly higher than the national norm. No implant-related deaths occurred. CONCLUSIONS: Results from 5 to 8 years of follow-up for a large number of subjects confirmed the safety of Natrelle round silicone implants, with no increased risk of systemic disease or suicide versus national norms or saline implants. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

SERI Surgical Scaffold in 2-Stage Breast Reconstruction: 2-Year Data from a Prospective, Multicenter Trial.

BACKGROUND: Soft-tissue support devices are used during breast reconstruction. This study investigated long-term clinical data following SERI Surgical Scaffold (SERI) implantation, a bioresorbable, silk-derived scaffold for soft-tissue support. METHODS: This was a prospective, multicenter study in 103 subjects who received SERI during stage 1 of 2-stage breast reconstruction with subpectoral tissue expander placement (Natrelle Style 133V; Allergan plc, Dublin, Ireland) followed by subpectoral breast implant placement. Investigator satisfaction (11-point scale: 0, very dissatisfied and 10, very satisfied) at 6 months was the primary endpoint. Ease of use, satisfaction, scaffold palpability/visibility, breast anatomy measurements via 3D images, SERI integration, histology, and safety were also assessed through 2 years after stage 1 surgery. RESULTS: Analyses were performed on the per-protocol population (103 subjects; 161 breasts) with no protocol deviations that could affect outcomes. Ease of use and subject and investigator satisfaction with SERI were high throughout 2 years. Breast anatomy measurements with 3D images demonstrated long-term soft-tissue stability of the lower breast mound. Key complication rates per breast were tissue/skin necrosis and wrinkling/rippling (8.1% each) and seroma, wound dehiscence, and breast redness (5.0% each). Over 2 years, 4 breasts in 4 subjects underwent reoperation with explantation of any device; 2 breasts required SERI explantation. SERI was retained in 98.8% of breasts (159/161) at 2 years. CONCLUSIONS: SERI was associated with high and consistent levels of investigator and subject satisfaction and demonstrated soft-tissue stability in the lower breast through 2 years. SERI provides a safe, long-term benefit for soft-tissue support in 2-stage breast reconstruction.

A Randomized, Controlled, Multicenter Study of Juvéderm Voluma for Enhancement of Malar Volume in Chinese Subjects.

BACKGROUND: Hyaluronic acid gels are used to restore volume to the midface, but there are few data published on this use in Asian subjects. METHODS: This study evaluated the safety and effectiveness in Chinese subjects of Juvéderm Voluma, a 20-mg/ml hyaluronic acid gel formulated for midface volumizing. This prospective, multicenter study randomized 119 subjects aged 18 years or older to a treatment group and 27 subjects to a no-treatment control group. The primary effectiveness endpoint was the objectively measured magnitude of change from baseline in volume of the midface area (right and left combined) calculated by digital analysis at month 6 using three-dimensional images for all subjects in both groups. Effectiveness was protocol-defined as a mean change for the treatment group that was significantly greater than that for the control group at month 6 using a one-side two-group t test performed at the 5 percent level. RESULTS: With a median volume of 2 ml of Voluma injected, the primary effectiveness endpoint was met, with the mean change from baseline to 6 months in malar volume for the treatment group (1.83 ml) being significantly greater than that for the control group (0.11 ml; p < 0.001). The secondary effectiveness endpoints of responder rate (malar volumization rated improved or much improved) using the Global Aesthetic Improvement Scale as assessed at month 6 by the investigator and by the subject were 98.2 and 93.8 percent, respectively. The most common treatment-related adverse events were mild injection-site swelling and bruising. CONCLUSION: Juvéderm Voluma is effective and well tolerated for midface augmentation in Chinese subjects. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Information Needs and Preferences of Parents Considering Treatment of Child Anxiety.

OBJECTIVE: To assess the information needs and preferences of parents who were making decisions concerning treatment for their child's anxiety. METHODS: Ninety-three parents were recruited from hospital-based clinics, a parent group, and a public information meeting. They completed a survey about preference for decision-making involvement, information needs, and preferences concerning source and amount of information. RESULTS: Most (69%) parents indicated that they prefer a collaborative decision-making role. They rated very highly the need for general information related to treatment and information related to psychosocial interventions and medication treatment. Fewer parents rated information about logistics of treatment (e.g., scheduling, cost) as highly important although this information was considered important by many parents. Direct discussions with a provider, written information, and information accessed through the internet were the most preferred sources of information. Many parents indicated a preference for substantial amounts of information about psychosocial and medication treatments. CONCLUSION: Much of the information that parents want concerning treatment is not widely available. It would be helpful to develop evidence-based brochures and web information resources that focus on answering parents' questions concerning treatment of children's anxiety.

Safety and Effectiveness of Juvéderm Ultra Plus Injectable Gel in Correcting Severe Nasolabial Folds in Chinese Subjects.

BACKGROUND: Hyaluronic acid dermal fillers are effective in correcting severe nasolabial folds (NLFs) in non-Asian populations. We assessed safety and effectiveness of Juvéderm Ultra Plus in a Chinese population. METHODS: This double-blind study randomized Chinese subjects with severe NLFs to Juvéderm Ultra Plus (24 mg/mL) in 1 NLF and Restylane injectable gel (20 mg/mL) in the other NLF. NLFs were evaluated using the validated 5-point photonumeric Allergan NLF Severity Scale (0 is "no wrinkle" and 4 is "very deep wrinkle"). Investigator-assessed responder rates (primary outcome at 6 months), NLF mean improvements, and subject-assessed responder rates and preference were assessed. RESULTS: Of 124 subjects randomized, 122 completed the 6-month visit. NLFs treated with Juvéderm Ultra Plus required less volume than those treated with Restylane (median [range]: 0.80 [0.3-2.0] vs 1.00 [0.3-1.9]; P<0.001). Investigator-assessed responder rates were 90.4% for Juvéderm Ultra Plus and 89.6% for Restylane, establishing noninferiority of Juvéderm Ultra Plus. Mean (SD) improvements in NLF Severity Scale scores from baseline at 6 months were 1.5 (0.75) for Juvéderm Ultra Plus and 1.6 (0.73) for Restylane. Subject-assessed responder rates were similar to investigator-assessed rates (87.3%, Juvéderm Ultra Plus; 83.9%, Restylane). Of subjects reporting a preference, 62.1% preferred Juvéderm Ultra Plus. The most common treatment site responses were swelling and tenderness; most were mild or moderate in severity and resolved without intervention. Juvéderm Ultra Plus had fewer severe treatment site responses than Restylane. CONCLUSION: In this study in Chinese subjects, Juvéderm Ultra Plus was safe and effective for correcting severe NLFs.

Safety and Effectiveness of VYC-15L, a Hyaluronic Acid Filler for Lip and Perioral Enhancement: One-Year Results From a Randomized, Controlled Study.

BACKGROUND: VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine. OBJECTIVE: To evaluate the safety and effectiveness of VYC-15L for lip and perioral enhancement versus a nonanimal stabilized HA with lidocaine (Restylane-L; NASHA). METHODS: This prospective multicenter study randomized 225 adults with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) to treatment with VYC-15L or NASHA; optional touch-up was administered 30 days later. Subjects were followed for 1 year. The primary effectiveness end point was noninferiority of VYC-15L versus NASHA by mean change in LFS score from baseline to Month 3. RESULTS: The primary end point was met. At Month 3, LFS responder rates were 80.3% for VYC-15L versus 70.8% for NASHA. LFS responder rates exceeded 60% through 1 year with VYC-15L. Perioral lines severity improved for 65.4% and 66.2% of VYC-15L subjects at Month 3 and Year 1, respectively. At Month 3, 96.1% and 88.2% of subjects reported improvement in FACE-Q Satisfaction With Lips and Satisfaction With Lip Lines, respectively. Severe injection site responses were reported less frequently with VYC-15L than NASHA. CONCLUSION: VYC-15L was safe and effective for lip and perioral enhancement, with treatment effects lasting through 1 year.

Nitrogen extraction potential of wild and cultured bivalves harvested from nearshore waters of Cape Cod, USA.

As nitrogen entering coastal waters continues to be an issue, much attention has been generated to identify potential options that may help alleviate this stressor to estuaries, including the propagation of bivalves to remove excess nitrogen. Oysters (Crassostrea virginica) and quahogs (Mercenaria mercenaria) from numerous Cape Cod, MA, (USA) sources were analyzed for nitrogen content stored in tissues that would represent a net removal of nitrogen from a water body if harvested. Results showed local oysters average 0.69% nitrogen by total dry weight (mean 0.28gN/animal) and quahogs average 0.67% nitrogen by total dry weight (mean 0.22gN/animal); however, these values did vary by season and to a lesser extent by location or grow-out method. The differences in nitrogen content were largely related to the mass of shell or soft tissue. Nitrogen isotope data indicate shellfish from certain water bodies in the region are incorporating significant amounts of nitrogen from anthropogenic sources.