Real-world assessment and treatment of locally advanced basal cell carcinoma: Findings from the RegiSONIC disease registry.

BACKGROUND: Limited information is available regarding real-world treatment patterns and their effectiveness and safety in patients with locally advanced basal cell carcinoma, including patients not typically represented in clinical trials. The purpose of the current study was to describe how clinicians diagnose and treat locally advanced basal cell carcinoma in the United States. METHODS: This prospective, multicenter, observational registry study included patients with newly diagnosed, Hedgehog pathway inhibitor-naive locally advanced basal cell carcinoma without basal cell carcinoma nevus syndrome (n = 433) treated at 75 US academic and community practices, including dermatology, Mohs surgery, and medical oncology sites. The main outcomes of this study were treatment patterns and associated effectiveness and safety for patients with locally advanced basal cell carcinoma in real-world settings. RESULTS: Determination of locally advanced basal cell carcinoma was mainly based on lesion size (79.6% of patients), histopathology (54.3%), extent of involvement (49.0%), and location (46.2%). Within 90 days of determination of locally advanced disease, 115 patients (26.6%) received vismodegib, 251 (58.0%) received surgery/other (non-vismodegib) treatment, and 67 (15.5%) had not yet received treatment (observation). Vismodegib-treated patients had a higher prevalence of high-risk clinical features predictive for locoregional recurrence than those with non-vismodegib treatment or observation. Clinical response rate was 85.1% with vismodegib and 94.9% with non-vismodegib treatment (primarily surgery). The most common adverse events with vismodegib were ageusia/dysgeusia, muscle spasms, alopecia, and weight loss. Rates of cutaneous squamous cell cancers were comparable between vismodegib and non-vismodegib treatment. CONCLUSIONS: This prospective observational study offers insight on real-world practice, treatment selection, and outcomes for a nationally representative sample of US patients with locally advanced basal cell carcinoma. For patients with lesions that were not amenable to surgery, vismodegib treatment was associated with effectiveness and safety that was consistent with that observed in clinical trials.

The Effects of Social, Personal, and Behavioral Risk Factors and PM2.5 on Cardio-Metabolic Disparities in a Cohort of Community Health Center Patients.

(1) Background: Cardio-metabolic diseases (CMD), including cardiovascular disease, stroke, and diabetes, have numerous common individual and environmental risk factors. Yet, few studies to date have considered how these multiple risk factors together affect CMD disparities between Blacks and Whites. (2) Methods: We linked daily fine particulate matter (PM2.5) measures with survey responses of participants in the Southern Community Cohort Study (SCCS). Generalized linear mixed modeling (GLMM) was used to estimate the relationship between CMD risk and social-demographic characteristics, behavioral and personal risk factors, and exposure levels of PM2.5. (3) Results: The study resulted in four key findings: (1) PM2.5 concentration level was significantly associated with reported CMD, with risk rising by 2.6% for each µg/m3 increase in PM2.5; (2) race did not predict CMD risk when clinical, lifestyle, and environmental risk factors were accounted for; (3) a significant variation of CMD risk was found among participants across states; and (4) multiple personal, clinical, and social-demographic and environmental risk factors played a role in predicting CMD occurrence. (4) Conclusions: Disparities in CMD risk among low social status populations reflect the complex interactions of exposures and cumulative risks for CMD contributed by different personal and environmental factors from natural, built, and social environments.

Inclusion of Lesbian, Gay, Bisexual, Transgender, Queer, and Intersex Health in Australian and New Zealand Medical Education.

PURPOSE: This study aims at establishing the scope of lesbian, gay, bisexual, transgender, queer, and intersex (LGBTQI) health in Australian and New Zealand medical curricula. METHODS: We sent medical school curriculum administrators an online cross-sectional survey. RESULTS: The response rate was 15 medical schools (71%): 14 Australian schools and 1 New Zealand school. Respondents included program directors (n = 5; 33%), course coordinators (n = 4; 27%), Heads of School (n = 2; 13%), one Dean (7%), and three others (20%). Most schools (n = 9; 60%) reported 0-5 hours dedicated to teaching LGBTQI content during the required pre-clinical phase; nine schools (60%) reported access to a clinical rotation site where LGBTQI patient care is common. In most schools (n = 9; 60%), LGBTQI-specific content is interspersed throughout the curriculum, but five schools (33%) have dedicated modules. The most commonly used teaching modalities include lectures (n = 12; 80%) and small-group sessions (n = 9; 60%). LGBTQI content covered in curricula is varied, with the most common topics being how to obtain information about same-sex sexual activity (80%) and the difference between sexual behavior and identity (67%). Teaching about gender and gender identity is more varied across schools, with seven respondents (47%) unsure about what is taught. Eight respondents (53%) described the coverage of LGBTQI content at their institution as "fair," two (13%) as "good," and two (13%) as "poor," with one respondent (7%) describing the coverage as "very poor." None of the respondents described the coverage as "very good." CONCLUSIONS: Currently, medical schools include limited content on LGBTQI health, most of which focuses on sexuality. There is a need for further inclusion of curriculum related to transgender, gender diverse, and intersex people.

Patient-reported impact of after-hours house-call services on the utilization of emergency department services in Australia.

Objectives: This paper explores, from the patients' perspective, the likely impact of the Australian after-hours house-call (AHHC) medical services on emergency department (ED) presentations. This has become imperative given the significant cost difference between patient presentations to either the AHHC or ED and their practical implications for health care funding. Design, setting and participants: A cross-sectional, self-reported survey of all 10 838 patients in Australia known to have patronized AHHC services over the last week of January 2016. Main outcome measure: The study used a validated, self-completion questionnaire, dispatched through a mixture of online and postal methods. Results: A total of 1228 questionnaires were returned, of which 1211 included all relevant sections of the survey (11.2% response rate). Four hundred and eighty-six patients (40.1%) indicated that they would have gone to the ED on the same day or night of their illness had the AHHC not been available, with the elderly (≥65) and children (<16) accounting for nearly two-thirds of these (64.6%). Following their AHHC consultations, 103 (8.5%) patients eventually attended the ED, meaning that the service prevented 383 patients from attending the ED, a decrease of 78.8%. Stratification based on location showed that this impact was seen across all states and territories in Australia where AHHC services exist, ranging from a reduction of 73.9% in Western Australia to 85.0% in Tasmania. Similarly, the impact cuts across all patient demographics, including age ranges, gender and social divides. Conclusions: Based on our respondents' reports, AHHC services appear to be associated with a reduction in ED visits in Australia, with the impact cutting across all regions and patient demographics.

International consensus statement on the assessment of interprofessional learning outcomes.

Regulatory frameworks around the world mandate that health and social care professional education programs graduate practitioners who have the competence and capability to practice effectively in interprofessional collaborative teams. Academic institutions are responding by offering interprofessional education (IPE); however, there is as yet no consensus regarding optimal strategies for the assessment of interprofessional learning (IPL). The Program Committee for the 17th Ottawa Conference in Perth, Australia in March, 2016, invited IPE champions to debate and discuss the current status of the assessment of IPL. A draft statement from this workshop was further discussed at the global All Together Better Health VIII conference in Oxford, UK in September, 2016. The outcomes of these deliberations and a final round of electronic consultation informed the work of a core group of international IPE leaders to develop this document. The consensus statement we present here is the result of the synthesized views of experts and global colleagues. It outlines the challenges and difficulties but endorses a set of desired learning outcome categories and methods of assessment that can be adapted to individual contexts and resources. The points of consensus focus on pre-qualification (pre-licensure) health professional students but may be transferable into post-qualification arenas.

Levels and predictors of patient satisfaction with doctor home-visit services in Australia.

BACKGROUND: The Australian after-hours house-call (AHHC) services has grown rapidly in the past few years. Even though recent studies have looked at aspects of the service as it concerns the medical personnel involved, no national study has explored patient satisfaction with the service. OBJECTIVE: This study aims to assess patient satisfaction with Australian AHHC services and its predictors, with the hope of improving quality and patient outcomes. The findings might also have international relevance, given the developing nature of the AHHC in most countries. METHODS: A cross-sectional survey of all 10838 patients known to have patronized the AHHC service in Australia over a 1-week period. The main outcome measure was the Patient Satisfaction Questionnaire 18 (PSQ-18). RESULTS: A total of 1228 questionnaires were returned. General Satisfaction (GS) level was found to be 85.2% (mean 4.16/5). Other Scales of Satisfaction, in decreasing order, were 'Financial Aspects, FA' (87.4%; 4.36/5), 'Communication, CM' (87.3%; 4.18), 'Technical Quality, TA' (82.1%; 4.09), 'Time Spent with Doctor, TSD' (77.7%; 3.91), 'Interpersonal Manner, IM' (75.7%; 3.87) and 'Accessibility and Convenience, A&C' (72.9%; 3.82). The major predictor of increased satisfaction was the time it took the doctor to arrive, with increased satisfaction on GS (T < 4 hours; P < 0.01), IM (T < 30 minutes; P = 0.03), FA (T < 2 hours; P = 0.01), TSD (T < 2 hours; P < 0.01) and A&C (T < 4 hours; P < 0.01). Other positive predictors of aspects of satisfaction included 'being a student', 'age of patient ≤ 16' and 'being Australian born', while 'being on a pension' was negatively associated with Communication (P = 0.03). No associations were found with gender, marital status, employment status, family income or having children in the household. CONCLUSIONS: This study concludes that satisfaction in Australian AHHC is high on all scales but recommends that the service providers should aim to attend to patients within 4 hours of their initial calls.

Objective Assessment of the Interfrontal Angle for Severity Grading and Operative Decision-Making in Metopic Synostosis.

BACKGROUND: The purpose of this study was to evaluate the utility of a previously validated interfrontal angle for classification of severity of metopic synostosis and as an aid to operative decision-making. METHODS: An expert panel was asked to study 30 cases ranging from minor to severe metopic synostosis. Based on computed tomographic images of the skull and clinical photographs, they classified the severity of trigonocephaly (1 = normal, 2 = mild, 3 = moderate, and 4 = severe) and management (0 = nonoperative and 1 = operative). The severity scores and management reported by experts were then pooled and matched with the interfrontal angle computed from each respective computed tomographic scan. A threshold was identified at which most experts agree on operative management. RESULTS: Expert severity scores were higher for more acute interfrontal angles. There was a high concordance at the extremes of classifications, severe (4) and normal (1) (p < 0.0001); however, between interfrontal angles of 114.3 and 136.1 degrees, there exists a "gray zone," with severe discordance in expert rankings. An operative threshold of 118.2 degrees was identified, with the interfrontal angle able to predict the expert panel's decision to proceed with surgery 87.6 percent of the time. CONCLUSIONS: The interfrontal angle has been previously validated as a simple, accurate, and reproducible means for diagnosing trigonocephaly, but must be obtained from computed tomographic data. In this article, the authors demonstrate that the interfrontal angle can be used to further characterize the severity of trigonocephaly. It also correlated with expert decision-making for operative versus nonoperative management. This tool may be used as an adjunct to clinical decision-making when the decision to proceed with surgery may not be straightforward. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, V.

Extractables analysis of single-use flexible plastic biocontainers.

UNLABELLED: Studies of the extractable profiles of bioprocessing components have become an integral part of drug development efforts to minimize possible compromise in process performance, decrease in drug product quality, and potential safety risk to patients due to the possibility of small molecules leaching out from the components. In this study, an effective extraction solvent system was developed to evaluate the organic extractable profiles of single-use bioprocess equipment, which has been gaining increasing popularity in the biopharmaceutical industry because of the many advantages over the traditional stainless steel-based bioreactors and other fluid mixing and storage vessels. The chosen extraction conditions were intended to represent aggressive conditions relative to the application of single-use bags in biopharmaceutical manufacture, in which aqueous based systems are largely utilized. Those extraction conditions, along with a non-targeted analytical strategy, allowed for the generation and identification of an array of extractable compounds; a total of 53 organic compounds were identified from four types of commercially available single-use bags, the majority of which are degradation products of polymer additives. The success of this overall extractables analysis strategy was reflected partially by the effectiveness in the extraction and identification of a compound that was later found to be highly detrimental to mammalian cell growth. LAY ABSTRACT: The usage of single-use bioreactors has been increasing in biopharmaceutical industry because of the appealing advantages that it promises regarding to the cleaning, sterilization, operational flexibility, and so on, during manufacturing of biologics. However, compared to its conventional counterparts based mainly on stainless steel, single-use bioreactors are more susceptible to potential problems associated with compound leaching into the bioprocessing fluid. As a result, extractable profiling of the single-use system has become essential in the qualification of such systems for its use in drug manufacturing. The aim of this study is to evaluate the effectiveness of an extraction solvent system developed to study the extraction profile of single-use bioreactors in which aqueous-based systems are largely used. The results showed that with a non-targeted analytical approach, the extraction solvent allowed the generation and identification of an array of extractable compounds from four commercially available single-use bioreactors. Most of extractables are degradation products of polymer additives, among which was a compound that was later found to be highly detrimental to mammalian cell growth.

Scalable combinatorial tools for health disparities research.

Despite staggering investments made in unraveling the human genome, current estimates suggest that as much as 90% of the variance in cancer and chronic diseases can be attributed to factors outside an individual's genetic endowment, particularly to environmental exposures experienced across his or her life course. New analytical approaches are clearly required as investigators turn to complicated systems theory and ecological, place-based and life-history perspectives in order to understand more clearly the relationships between social determinants, environmental exposures and health disparities. While traditional data analysis techniques remain foundational to health disparities research, they are easily overwhelmed by the ever-increasing size and heterogeneity of available data needed to illuminate latent gene x environment interactions. This has prompted the adaptation and application of scalable combinatorial methods, many from genome science research, to the study of population health. Most of these powerful tools are algorithmically sophisticated, highly automated and mathematically abstract. Their utility motivates the main theme of this paper, which is to describe real applications of innovative transdisciplinary models and analyses in an effort to help move the research community closer toward identifying the causal mechanisms and associated environmental contexts underlying health disparities. The public health exposome is used as a contemporary focus for addressing the complex nature of this subject.

Personalized assessment of craniosynostosis via statistical shape modeling.

We present a technique for the computational analysis of craniosynostosis from CT images. Our fully automatic methodology uses a statistical shape model to produce diagnostic features tailored to the anatomy of the subject. We propose a computational anatomy approach for measuring shape abnormality in terms of the closest case from a multi-atlas of normal cases. Although other authors have tackled malformation characterization for craniosynostosis in the past, our approach involves several novel contributions (automatic labeling of cranial regions via graph cuts, identification of the closest morphology to a subject using a multi-atlas of normal anatomy, detection of suture fusion, registration using masked regions and diagnosis via classification using quantitative measures of local shape and malformation). Using our automatic technique we obtained for each subject an index of cranial suture fusion, and deformation and curvature discrepancy averages across five cranial bones and six suture regions. Significant differences between normal and craniosynostotic cases were obtained using these characteristics. Machine learning achieved a 92.7% sensitivity and 98.9% specificity for diagnosing craniosynostosis automatically, values comparable to those achieved by trained radiologists. The probability of correctly classifying a new subject is 95.7%.

Cost of treating sagittal synostosis in the first year of life.

BACKGROUND: Endoscopically assisted suturectomy (EAS) has been reported to reduce the morbidity and cost of treating sagittal synostosis when compared with traditional open cranial vault remodeling (CVR) procedures. Whereas the former claim is well substantiated and intuitive, the latter has not been validated by rigorous cost analysis. METHODS: Patient medical records and financial database reports were culled retrospectively to determine the total cost associated with both EAS and CVR during 1 year of care. Recorded cost data included physician and hospital services, orthotic equipment and fittings, and indirect patient cost. RESULTS: Ten patients treated with CVR were compared with 10 patients who underwent EAS. The CVR patients incurred greater costs in nearly all categories studied, including overall 1-year costs, physician services, hospital services, supplies/equipment, medications/intravenous fluids, and laboratory and blood bank services. Postoperative costs were greater in the EAS group, primarily because of the cost associated with orthotic services and indirect patient costs for travel and lost work. However, overall indirect patient costs for the whole year did not differ between the groups. One-year median costs were $55,121 for CVR and $23,377 for EAS. Early clinical results were similar for the 2 groups. CONCLUSIONS: Cranial vault remodeling was more costly in the first year of treatment than EAS, although indirect patient costs were similar. The favorable cost of EAS compared with CVR provides further justification to consider this procedure as first-line treatment of sagittal synostosis in young infants.

Perioperative corticosteroid reduces hospital stay after fronto-orbital advancement.

Facial swelling is common after fronto-orbital advancement. Edema and closure of the palpebral fissures can lead to prolonged hospitalization. The purpose of this study was to determine if perioperative corticosteroid shortens hospital stay after this procedure.We retrospectively studied consecutive children younger than 2 years who underwent primary fronto-orbital advancement between 1990 and 2008. Patients were categorized into 2 groups: group 1 patients were not given corticosteroid; group 2 patients received tapered perioperative dexamethasone. Primary outcome variables included length of hospital stay and infection rate.A total of 161 patients were included in the study. Hospitalization was significantly shorter (P = 0.008) for group 2 (n = 65; median duration, 3.0 d) than group 1 (n = 96; median duration, 5.0 d). Infection rates did not differ between groups (group 1, 2.1%; group 2, 1.5%; P = 0.8).Perioperative corticosteroid shortens hospitalization after fronto-orbital advancement without increasing the incidence of postoperative infection. The cost of postoperative hospital care was reduced by 27.2%.

Social factors associated with Major Depressive Disorder in homosexually active, gay men attending general practices in urban Australia.

OBJECTIVES: Social factors associated with Major Depressive Disorder (MDD) were identified among gay men attending high HIV caseload general practices in Sydney and Adelaide. METHODS: Men who visited four participating practices were invited to self-complete a survey. A self-screening tool (PHQ-9), based on the Diagnostic and Statistical Manual of Mental Disorders, version four (DSM-IV), was used to measure depressive disorders. RESULTS: The rate of MDD (PHQ-9 score 10 or above) among the 195 HIV-positive gay men was significantly higher than that among the 314 non-HIV-positive gay men (31.8% vs 20.1%, p=0.002). Current MDD was independently associated with younger age, lower income, recent major adverse life events, adopting denial and isolation as coping strategies, less social support, less gay community involvement and recent sexual problems. HIV-status, however, was not independently associated with MDD. CONCLUSION: Socio-economic hardship, interpersonal isolation and personal withdrawal were significantly and independently associated with major depression in this population of gay men. IMPLICATIONS: The study provides further evidence of health inequity affecting gay men in Australia. Structural health promotion approaches focused on homophobia and discrimination, as well as community-engaged primary health care responses are called for to mitigate this inequity.

Palatoplasty outcomes in nonsyndromic patients with cleft palate: a 29-year assessment of one surgeon's experience.

The primary objective of cleft palate repair is velopharyngeal competence without fistula. The reported incidence of fistula and velopharyngeal insufficiency (VPI) is variable. Our purpose was to assess the senior surgeon's 29-year palatoplasty experience with respect to incidence of fistula and VPI. Our hypotheses were that VPI is related to (1) age at palatoplasty, (2) cleft palate type, and (3) VPI and palatal fistula incidence decrease with the surgeon's experience. We reviewed the records of all children with cleft palate treated by the senior author between 1976 and 2004. Cleft palate was categorized according to Veau. Palatoplasty was performed on 449 patients, using a 2-flap technique with muscular retropositioning. The mean age at palatoplasty was 11.6 +/- 4.9 months (range, 7.0-46.4 months). The incidence of palatal fistula was 2.9%, and velopharyngeal sufficiency was found in 85.1% of patients. We found a significant association between age at palatoplasty and VPI (P = 0.009, odds ratio, 1.06 [95% confidence interval, 1.02-1.10]). Velopharyngeal insufficiency was also associated with the Veau hierarchy (P = 0.001). Incidence of VPI was independent of surgeon experience (P = 0.2). In conclusion, the incidence of palatal fistula was low. Velopharyngeal insufficiency was associated with increasing age at palatoplasty and with the Veau hierarchy.

Health priorities and perceived health determinants among South Australians attending GLBTI festival events.

ISSUE ADDRESSED: Health differentials related to the social position of people whose sexual attraction or gender identity differs from that of the majority may be the 'forgotten inequity' in contemporary Australian discourses on health inequalities and social inclusion. What sexually- and gender-diverse communities see as health priorities and the social determinants of their health have been little studied in Australia. This survey explored the experience and opinions of a convenience sample of gay, lesbian, bisexual, trangender and intersex (GLBTI) people in South Australia. METHOD: A pencil and paper survey was administered to people attending events associated with the Feast GLBTI festival in Adelaide in 2004 and good participation rates were obtained. Two hundred and fifty-three people completed the survey, of which 122 identified as female, 124 as male and seven as other genders. RESULTS: Depression, HIV, suicide, family relationship problems and alcohol problems were seen as the most important health issues for these communities, while discrimination under the law and in daily life were rated the most important health determinants. CONCLUSIONS: GLBTI South Australians surveyed identified priority health issues for their communities and identified legal and personal discrimination as significant determinants of their health.

Caring for a marginalised community: the costs of engaging with culture and complexity.

The Care and Prevention Programme (CPP) began in 1998. It is based on the philosophy of primary health care, and has improved health among homosexually active men, including about a third of HIV-positive South Australians. The CPP was assessed using financial analysis and qualitative methods. Participants wanted to access care where they could feel comfortable and safe to talk about issues of sexuality and lifestyle. The CPP model is "economically" sustainable, but not "financially" sustainable within the Medicare Benefits Schedule. It is vulnerable to changes in political environment. The financing model for the CPP has been adapted by including state funding. General practitioners have adapted by lowering their personal incomes (but not quality of care). These adaptations have achieved fragile financial viability. Facilitators of sustainability for the CPP included: It is part of the community that it serves; The creation of deeply integrated networks of diversity-competent service providers; and "Virtuous non-adaptability" of service providers in refusing to compromise care standards despite financial pressure to do so. Threats to sustainability included: Difficulty maintaining a diversity-competent workforce skilled in HIV medicine; Marginal financial viability; and Political vulnerability.