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On 7 September 2017, the U.S. Air Force Research Laboratory launched the second Advanced Structurally Embedded Thermal Spreader (ASETS-II) flight experiment on the fifth flight [Orbital Test Vehicl...

Introduction The increased use of long-acting reversible contraceptives (LARCs), such as intrauterine devices and hormonal implants, has the potential to reduce unintended pregnancy and abortion rates. However, use of LARCs in Australia is very low, despite clinical practice guidance and statements by national and international peak bodies advocating their increased use. This protocol paper describes the Australian Contraceptive ChOice pRojet (ACCORd), a cluster randomised control trial that aims to test whether an educational intervention targeting general practitioners (GPs) and establishing a rapid referral service are a cost-effective means of increasing LARC uptake. Methods and analysis The ACCORd intervention is adapted from the successful US Contraceptive CHOICE study and involves training GPs to provide ‘LARC First’ structured contraceptive counselling to women seeking contraception, and implementing rapid referral pathways for LARC insertion. Letters of invitation will be sent to 600 GPs in South-Eastern Melbourne. Using randomisation stratified by whether the GP inserts LARCs or not, a total of 54 groups will be allocated to the intervention (online ‘LARC First’ training and rapid referral pathways) or control arm (usual care). We aim to recruit 729 women from each arm. The primary outcome will be the number of LARCs inserted; secondary outcomes include the women's choice of contraceptive method and quality of life (Short Form Health Survey, SF-36). The costs and outcomes of the intervention and control will be compared in a cost-effectiveness analysis. Ethics and dissemination The ACCORd study has been approved by the Monash University Human Research Ethics Committee: CF14/3990-2014002066 and CF16/188-2016000080. Any protocol modifications will be communicated to Ethics Committee and Trial Registration registry. The authors plan to disseminate trial outcomes through formal academic pathways comprising journal articles, nation and international conferences and reports, as well as using more ‘popular’ strategies including seminars, workshops and media engagements. Trial registration number ACTRN12615001346561.

Introduction Maternal mortality is a potentially preventable public health issue. Maternal morbidity is increasingly of interest to aid the reduction of maternal mortality. Obstetric patients admitted to the intensive care unit (ICU) are an important part of the global burden of maternal morbidity. Social determinants influence health outcomes of pregnant women. Additionally, intimate partner violence has a great negative impact on women9s health and pregnancy outcome. However, little is known about the contextual and social aspects of obstetric patients treated in the ICU. This study aimed to conduct a systematic review of the social determinants and exposure to intimate partner violence of obstetric patients admitted to an ICU. Methods and analysis A systematic search will be conducted in MEDLINE, CINAHL, ProQuest, LILACS and SciELO from 2000 to 2016. Studies published in English and Spanish will be identified in relation to data reporting on social determinants of health and/or exposure to intimate partner violence of obstetric women, treated in the ICU during pregnancy, childbirth or within 42 days of the end of pregnancy. Two reviewers will independently screen for study eligibility and data extraction. Risk of bias and assessment of the quality of the included studies will be performed by using the Critical Appraisal Skills Programme (CASP) checklist. Data will be analysed and summarised using a narrative description of the available evidence across studies. This systematic review protocol will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) guidelines. Ethics and dissemination Since this systematic review will be based on published studies, ethical approval is not required. Findings will be presented at La Trobe University, in Conferences and Congresses, and published in a peer-reviewed journal. Trial registration number CRD42016037492.

Domestic violence creates multiple harms for women's health and is a ‘wicked problem’ for health professionals and public health systems. Brazil recently approved public policies to manage and care for women victims of domestic violence. Facing these policies, this study aimed to explore how domestic violence against women is usually managed in Brazilian primary health care, by investigating a basic health unit and its family health strategy. We adopted qualitative ethnographic research methods with thematic analysis of emergent categories, interrogating data with gender theory and emergent Brazilian collective health theory. Field research was conducted in a local basic health unit and the territory for which it is responsible, in Southern Brazil. The study revealed: 1) a yawning gap between public health policies for domestic violence against women at the federal level and its practical application at local/decentralized levels, which can leave both professionals and women unsafe; 2) the key role of local community health workers, paraprofessional health promotion agents, who aim to promote dialogue between women experiencing violence, health care professionals and the health care system. Resumo A violência doméstica (VD) cria múltiplos agravos à saúde das mulheres e é um desafio para profissionais e para os sistemas de saúde. O Brasil aprovou recentemente políticas públicas (PP) para manejo e cuidado de mulheres em situação de VD. Considerando essas PP, este estudo objetivou explorar como a VD contra mulheres é usualmente manejada na atenção primária à saúde brasileira, por meio da investigação de uma unidade básica de saúde e de sua estratégia de saúde da família. Foi adotada metodologia de pesquisa qualitativa de cunho etnográfico, com análise temática de categorias emergentes, interrogando os dados com teoria de gênero e com a produção teórica do campo da saúde coletiva brasileira. A pesquisa de campo foi conduzida em uma unidade básica de saúde e em seu território adscrito, localizado na região sul do Brasil. O estudo revelou: 1) um hiato entre PP direcionadas à VD contra mulheres implantadas a nível federal e sua aplicação prática a nível local/descentralizado, que pode deixar tanto profissionais quanto mulheres em risco; 2) o papel chave de agentes comunitários de saúde, profissionais de promoção da saúde, que objetivam promover o diálogo entre as mulheres experienciando violência, profissionais de saúde e o sistema de saúde.

Background & Aims Patient symptom reporting often does not correlate with the pathophysiological markers of esophageal disease, including eosinophilic esophagitis (EoE). Esophageal hypervigilance and symptom-specific anxiety are emerging as important considerations in understanding symptom reporting. As such, we aimed to conduct the first study of these constructs in EoE. Methods A retrospective review of an EoE patient registry was conducted and included eosinophils per high power field (from esophagogastroduodenoscopy biopsy: proximal, distal), endoscopic reference score, distal distensibility plateau (functional luminal imaging probe), Brief Esophageal Dysphagia Questionnaire, Visual Dysphagia Question of EoE Activity Index, Northwestern Esophageal Quality of Life scale, and the Esophageal Hypervigilance and Anxiety Scale. Correlational and regression analyses evaluated relationships of hypervigilance and anxiety with Brief Esophageal Dysphagia Questionnaire, Visual Dysphagia Question of EoE Activity Index, and Northwestern Esophageal Quality of Life scale when controlling for histology and endoscopic severity. Results One hundred and three patients had complete data, 69.9% were male, and the mean (SD) age was 40.66 (13.85) years. Forty-one percent had elevated dysphagia and 46% had elevated hypervigilance and anxiety. Esophageal symptom–specific anxiety emerged as the most important predictor of Brief Esophageal Dysphagia Questionnaire severity (44.8% of the variance), Visual Dysphagia Question of EoE Activity Index severity (26%), and poor health-related quality of life (HRQoL) (55.3%). Hypervigilance was also important, but to a lesser extent. Pathophysiological variables did not significantly predict symptoms or HRQoL. Recent food impaction can predict symptom-specific anxiety and proton pump inhibitor use can reduce hypervigilance. Conclusions Hypervigilance and symptom-specific anxiety are important for our understanding of self-reported patient outcomes in EoE. These processes outweigh endoscopic and histologic markers of EoE disease activity across dysphagia, difficulty eating, and HRQoL. Clinicians should assess hypervigilance and anxiety, especially in patients with refractory symptoms and poor HRQoL.

Purpose This paper aims to understand social entrepreneurship (SE) business model design to create values whilst undertaking public service delivery within the complex environments of local governments in South Africa. Design/methodology/approach Face-to-face semi-structured interview was conducted with 15 purposively selected social entrepreneurs in Gauteng and Western Cape provinces. The interview guide consisted of main themes and follow-up questions. Themes included SEs’ general history, the social business model; challenges faced and how these were overcome; scaling and growth/survival strategies. These enabled the evaluation of SEs in terms of identifying key criteria of affordability, availability, awareness and acceptability, which SEs must achieve to operate successfully in low-income markets. Social enterprise owners/managers within the electricity distribution, water reticulation and waste management services sectors were surveyed. Findings Most respondents focus on building a network of trust with stakeholders, through communication mechanisms that emphasize high-frequency engagements. There is also a strong focus on design-thinking and customer-centric approaches that strengthen value creation. The value creation process used both product value and service value mechanisms and emphasized quality and excellence to provide stakeholder, as well as societal value, within their specific contexts. Practical implications This study builds upon other research that emphasizes SEs’ customer-centric approaches to strengthen value creation and on building a network of trust with multiple stakeholders. It contributes to emphasizing the business paradigm shift towards bringing social values to the business practice. Social implications Social good, but resource providers are demanding more concrete evidence to help them understand their impact (Struthers, 2013). This is because it is intrinsically difficult for many social organizations to document and communicate their impact in more than an anecdotal way. The research has contributed to the understanding of how SEs can provide evidence of value creation. Originality/value This study contributes to the understanding of how business models are designed to create value within the context of the overwhelming complexity of local government services in South Africa.

The Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) collaborators are a group of more than 70 gastroenterologists, pathologists, allergists, researchers, dietitians, psychologists, and methodologists who convened in a series of in-person and virtual meetings between 2018 and 2020 with the aim of developing a core outcome set (COS) for use in therapeutic studies of pharmacologic and dietary therapies for the treatment of eosinophilic esophagitis (EoE). Given heterogeneity in reported outcomes and uncertainties regarding the most appropriate end points for use in both randomized controlled trials (RCTs) and observational studies involving EoE patients, the EoE experts launched the COREOS exercise in 2018 to standardize outcome definitions using methods established by the Core Outcome Measures in Effectiveness Trials (COMET) initiative.1,2 The COS was developed using a multiphase approach, which is summarized in Figure 1. In the first phase, systematic reviews of the literature and patient engagement surveys were conducted to identify candidate outcomes that have been previously measured and are important to patients with EoE. Next, this information was used to build a framework of different outcome domains, and working groups for each domain were assembled to review the literature for relevant end points.3–6 The relative importance of these domains was categorized in a Delphi survey as core, important, and research agenda domains, and discussed in a moderated in-person meeting on May 17, 2019 at Digestive Disease Week (San Diego, CA). In phase 3, a comprehensive list of outcome measures within each of the core domains was evaluated by the COREOS collaborators in a 2-round Delphi survey and, finally, outcomes were ratified in a virtual meeting on December 8, 2020. In this meeting summary, we highlight the major points of discussion that occurred during the development of the EoE COS.

We recently observed a high prevalence of low pelvic bone mineral density (BMD) in female professional ballet performers. Because this population is susceptible to musculoskeletal overuse injuries, we aimed to determine which regions of the pelvis may be at greatest risk compared to general population females (GENPOP) as well as professional female soccer players (SOCCER, a comparison to other elite athletes regularly subjected to high degrees of loading). Three groups of age-matched females [(GENPOP; n = 38, 27±1yrs), (BALLET; single company, n = 36, 26±3yrs), (SOCCER; single NWSL® club, n = 34, 25±1yrs)] consented to have their BMD and body composition assessed (DEXA, GE®). In addition to soft tissue and total and regional BMD analyses, a segmental analysis of the pelvis was performed to determine site-specific BMD for the iliac fossa, iliac fossa/iliac crest/ilium combined, pubic bone, ischium, and sacrum. A mixed-model ANOVA followed by a Tukey's post-hoc test was used to compare the groups (Type-I error; α = 0.05). The BALLET group had lower pelvic BMD for all measures (Avg.%Diff. = 15%-27%, p

Background and objectives Women’s ability to negotiate condom use helps prevent sexually transmissible infections (STIs) and unintended pregnancies. The aim of this study was to assess the relationship between substance use, risk perception and the certainty of using condoms in several hypothetical situations. Methods This is a secondary analysis from the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial. Descriptive statistics and logistic regression were used for the analysis. Results At baseline, contraceptive questions were answered by 698 women attending 57 general practices in Melbourne, Australia. Condom use was reported by 47%. Of those using condoms as the sole form of contraception (n = 137), 20% used them inconsistently. Dual protection was used by 58% of women (188/325). Condoms and the pill were more frequently used than condoms and longer-acting contraceptives. Women were less likely to be confident negotiating condom use when using substances. Discussion Substance use and the concurrent use of other forms of contraception impact use of condoms. Even when condoms are the sole form of contraception with willing partners, use is inconsistent, leaving women at risk of pregnancy and STI.

Background: Although graft choice may be limited in the revision setting based on previously used grafts, most surgeons believe that graft choice for anterior cruciate ligament (ACL) reconstruction is an important factor related to outcome. Hypothesis: In the ACL revision setting, there would be no difference between autograft and allograft in rerupture rate and patient-reported outcomes (PROs) at 6-year follow-up. Study Design: Cohort study; Level of evidence, 2. Methods: Patients who had revision surgery were identified and prospectively enrolled in this cohort study by 83 surgeons over 52 sites. Data collected included baseline characteristics, surgical technique and pathology, and a series of validated PRO measures. Patients were followed up at 6 years and asked to complete the identical set of PRO instruments. Incidence of additional surgery and reoperation because of graft failure were also recorded. Multivariable regression models were used to determine the predictors (risk factors) of PROs, graft rerupture, and reoperation at 6 years after revision surgery. Results: A total of 1234 patients including 716 (58%) men were enrolled. A total of 325 (26%) underwent revision using a bone-patellar tendon-bone (BTB) autograft; 251 (20%), soft tissue autograft; 289 (23%), BTB allograft; 302 (25%), soft tissue allograft; and 67 (5%), other graft. Questionnaires and telephone follow-up for subsequent surgery information were obtained for 809 (66%) patients, while telephone follow-up was only obtained for an additional 128 patients for the total follow-up on 949 (77%) patients. Graft choice was a significant predictor of 6-year Marx Activity Rating Scale scores ( P = .024). Specifically, patients who received a BTB autograft for revision reconstruction had higher activity levels than did patients who received a BTB allograft (odds ratio [OR], 1.92; 95% CI, 1.25-2.94). Graft rerupture was reported in 5.8% (55/949) of patients by their 6-year follow-up: 3.5% (16/455) of patients with autografts and 8.4% (37/441) of patients with allografts. Use of a BTB autograft for revision resulted in patients being 4.2 times less likely to sustain a subsequent graft rupture than if a BTB allograft were utilized ( P = .011; 95% CI, 1.56-11.27). No significant differences were found in graft rerupture rates between BTB autograft and soft tissue autografts ( P = .87) or between BTB autografts and soft tissue allografts ( P = .36). Use of an autograft was found to be a significant predictor of having fewer reoperations within 6 years compared with using an allograft ( P = .010; OR, 0.56; 95% CI, 0.36-0.87). Conclusion: BTB and soft tissue autografts had a decreased risk in graft rerupture compared with BTB allografts. BTB autografts were associated with higher activity level than were BTB allografts at 6 years after revision reconstruction. Surgeons and patients should consider this information when choosing a graft for revision ACL reconstruction.

Background Patients with chronic illness are at increased risk for traumatic stress because of medical trauma. Initial studies of posttraumatic stress (PTS) in patients with inflammatory bowel disease (IBD) have found that approximately one-third of patients may experience significant PTS symptoms including flashbacks, nightmares, hypervigilance, disrupted sleep, and low mood. We aim to better characterize PTS in IBD and its relationship with patient outcomes in a large cohort of patients with IBD. Methods Adult patients registered with the Crohn’s & Colitis Foundation/University of North Carolina IBD Partners database were invited to complete a supplementary survey between February and July 2020. The Post Traumatic Stress Disorder Checklist-5th edition was administered as a supplemental survey. Additional data from IBD Partners included disease severity, surgery and hospital history, demographics, and health care utilization. Results A total of 797 patients participated (452 with Crohn disease, 345 with ulcerative colitis). No impacts on response patterns because of the COVID-19 pandemic were found. Although 5.6% of the sample reported an existing PTS diagnosis because of IBD experiences, 9.6% of participants met the full IBD-related PTS diagnostic criteria per the Post Traumatic Stress Disorder Checklist-5th edition. Female patients, younger patients, those with less educational attainment, non-White patients, and Hispanic patients reported higher levels of PTS symptoms. Patients with higher PTS symptoms were more likely to have been hospitalized, have had surgery, have more severe symptoms, and not be in remission. Increased PTS was also associated with increased anxiety, depression, pain interference, fatigue, and health care utilization. Conclusions The present findings support prior research that approximately one-quarter to one-third of patients with IBD report significant symptoms of PTS directly from their disease experiences, and certain demographic groups are at higher risk. In addition, PTS is associated with several IBD outcomes. Patients with higher PTS symptoms are less likely to be in remission and may utilize more outpatient gastrointestinal services. Intervention trials to mitigate PTS symptoms in patients with IBD are warranted.

Background: Although blood flow restriction (BFR) is becoming increasingly popular in physical therapy and athletic training settings, little is known about the effects of BFR combined with low-intensity exercise (LIX) on muscles proximal to the site of occlusion. Hypothesis/Purpose: Determine whether LIX combined with BFR applied distally to the shoulder on the brachial region of the arm (BFR-LIX) promotes greater increases in shoulder lean mass, rotator cuff strength, endurance, and acute increases in shoulder muscle activation compared with LIX alone. We hypothesized that BFR-LIX would elicit greater increases in rotator cuff strength, endurance, and muscle mass. We also hypothesized that the application of BFR would increase EMG amplitude in the shoulder muscles during acute exercise. Study Design: Controlled laboratory study. Methods: 32 healthy adults were randomized into 2 groups (BFR group, 13 men, 3 women; No-BFR group, 10 men, 6 women) who performed 8 weeks of shoulder LIX (2 times per week; 4 sets [30/15/15/fatigue]; 20% maximum) using common rotator cuff exercises (cable external rotation [ER], cable internal rotation [IR], dumbbell scaption, and side-lying dumbbell ER). The BFR group also trained with an automated tourniquet placed at the proximal arm (50% occlusion). Regional lean mass (dual-energy x-ray absorptiometry), isometric strength, and muscular endurance (repetitions to fatigue [RTF]; 20% maximum; with and without 50% occlusion) were measured before and after training. Electromyographic amplitude (EMGa) was recorded from target shoulder muscles during endurance testing. A mixed-model analysis of covariance (covaried on baseline measures) was used to detect within-group and between-group differences in primary outcome measures (α = .05). Results: The BFR group had greater increases in lean mass in the arm (mean ± 95% CI: BFR, 175 ± 54 g; No BFR, –17 ± 77 g; P < .01) and shoulder (mean ± 95% CI: BFR, 278 ± 90 g; No BFR, 96 ± 61 g; P < .01), isometric IR strength (mean ± 95% CI: BFR, 2.9 ± 1.3 kg; No BFR, 0.1 ± 1.3 kg; P < .01), single-set RTF volume (repetitions × resistance) for IR (~1.7- to 2.1-fold higher; P < .01), and weekly training volume (weeks 4, 6-8, ~5%-22%; P < .05). Acute occlusion (independent of group or timepoint) yielded increases in EMGa during RTF (~10%-20%; P < .05). Conclusion: Combined BFR-LIX may yield greater increases in shoulder and arm lean mass, strength, and muscular endurance compared with fatiguing LIX alone during rotator cuff exercises. These findings may be due, in part, to a greater activation of shoulder muscles while using BFR. Clinical Relevance: The present study demonstrates that BFR-LIX may be a suitable candidate for augmenting preventive training or rehabilitation outcomes for the shoulder.

Spinal muscular atrophy with congenital bone fractures 2 (SMABF2), a type of arthrogryposis multiplex congenita (AMC), is characterized by congenital joint contractures, prenatal fractures of long bones, and respiratory distress and results from biallelic variants in ASCC1. Here, we describe an infant with severe, diffuse hypotonia, congenital contractures, and pulmonary hypoplasia characteristic of SMABF2, with the unique features of cleft palate, small spleen, transverse liver, and pulmonary thromboemboli with chondroid appearance. This infant also had impaired coagulation with diffuse petechiae and ecchymoses which has only been reported in one other infant with AMC. Using trio whole genome sequencing, our proband was identified to have biallelic variants in ASCC1. Using deep next generation sequencing of parental cDNA, we characterized alteration of splicing encoded by the novel, maternally inherited ASCC1 variant (c.297-8 T > G) which provides a mechanism for functional pathogenicity. The paternally inherited ASCC1 variant is a rare nonsense variant (c.466C > T; p.Arg156*) that has been previously identified in one other infant with AMC. This report extends the phenotypic characteristics of ASCC1-associated AMC (SMABF2) and describes a novel intronic variant that partially disrupts RNA splicing.

Psychogastroenterology is the specialty treatment of patients living with chronic illnesses that affect the digestive tract using evidence-based methods, the most often being cognitive behavioral therapy tailored to the digestive illness and gut-directed hypnotherapy. While patients with all digestive conditions are referred for services, the most common are irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD). Clinical interventions target disease processes, including visceral hypersensitivity and autonomic nervous system arousal, while leveraging resilience and coping strategies to enhance patient self-management of their disease. Opportunities exist for psychologists both in integrated gastroenterology clinics and in private practice settings. The protocols and clinical process of working with the patient are described in detail.

PURPOSE OF REVIEW: Social media use by patients with inflammatory bowel disease (IBD) and their respective providers continues to increase, promoting disease awareness and scholarship. In this review article, we summarize the current literature regarding social media use and IBD, discuss both the patient and physician perspective, and provide guidance to avoid commonly encountered pitfalls. RECENT FINDINGS: Patients and providers commonly rely on social media to share medical information, advocate for improved IBD care, and to network and collaborate on common research interests. This shift from more traditional formats of education and networking continues to grow exponentially, and even more rapidly so during the COVID-19 pandemic. SUMMARY: Social media use in the IBD community will continue to grow and lead to further innovation. Providers should be aware of social media as a valuable tool for their patients and themselves.

Background: The Australian Contraceptive ChOice pRoject (ACCORd) aimed to assess the impact of a complex general practice intervention on the uptake of long-acting reversible contraceptives (LARC). Aims: Using survey data from enrolled women, we aimed to compare the ongoing use and satisfaction of women who chose one of the hormonal LARC methods including the levonorgestrel intrauterine system (LNG-IUS) or levonorgestrel implant compared to the oral contraceptive pill (OCP). Materials and Methods: We used the data from participants’ baseline, six and 12-month surveys to identify new users of implants, LNG-IUS or OCP. We included demographic information, ongoing use of the contraceptive method, reasons for dissatisfaction and discontinuation and experience of side-effects. Proportions were compared using χ tests. Results: Of the 740 women enrolled in ACCORd, 176 started using a hormonal LARC or OCP in the study’s first six months with 76 using the IUS (43%), 60 the implant (34%) and 40 (23%) the OCP. Twelve-month continuation rates for the LNG-IUS, implant and OCP were 93, 83 and 65% respectively (P < 0.001). Satisfaction was highest among the LNG-IUS users; 86% were very/somewhat satisfied compared to 75% of implant users and 61% of OCP users (P < 0.001). Main reasons for method dissatisfaction were irregular bleeding and mood changes which were similar for all methods. Conclusions: This study provides further evidence that hormonal LARC methods have higher continuation and satisfaction rates compared to the OCP with similar side-effects. Since hormonal LARC methods have the highest contraceptive efficacy, these should be offered first-line to women.

BACKGROUND: Direct-acting antivirals (DAAs) are expected to improve outcomes for patients with hepatitis C virus (HCV) infection after liver transplantation (LT). We aim to evaluate trends in post-LT outcomes with availability of DAAs. METHODS: We retrospectively evaluated US adults transplanted from January 1, 2002, to March 31, 2018, using the United Network for Organ Sharing Registry, stratified by pre-DAA (January 1, 2002– to December 31, 2013) vs. post-DAA (January 1, 2014–, to March 31, 2018) eras. Adjusted multivariate Cox regression analyses and competing risk models evaluated likelihood of graft failure, death, and retransplantation (re-LT). RESULTS: Among 97,147 patients, 30.2% had HCV infection and 19.4% had hepatocellular carcinoma (HCC). Of all patients, 31.9% experienced graft failure, 27.1% died after LT, and 4.7% underwent re-LT. The post-DAA era experienced lower likelihood of graft failure (hazard ratio [HR] = 0.69, p

This paper describes work in progress on a workflow that supports consistent property-preservation proofs from early stages of system requirements specifications down to software requirements and final implementation. This workflow, called System-to-Software Integrity (SSI), demonstrates that the implemented software satisfies constraints defined in system requirements.

Infection is a rare occurrence after revision anterior cruciate ligament reconstruction (rACLR). Because of the low rates of infection, it has been difficult to identify risk factors for infection in this patient population. The purpose of this study was to report the rate of infection following rACLR and assess whether infection is associated with patient- and surgeon- dependent risk factors. We reviewed two large prospective cohorts to identify patients with postoperative infections following rACLR. Age, sex, body mass index (BMI), smoking status, history of diabetes, and graft choice were recorded for each patient. The association of these factors with postoperative infection following rACLR was assessed. There were 1423 rACLR cases in the combined cohort, with 9 (0.6%) reporting post-operative infections. Allografts had a higher risk of infection than autografts (odds ratio=6.8; 95% CI: 0.9-54.5; p=0.045). Diabetes (odds ratio=28.6; 95% CI: 5.5-149.9; p=0.004) was a risk factor for infection. Patient age, sex, BMI and smoking status were not associated with risk of infection after rACLR. STATEMENT OF CLINICAL SIGNIFICANCE: While there is a low rate of infection following rACLR, use of allograft and comorbidity with diabetes are associated with a higher risk of infection following this surgery.

Background: Meniscal preservation has been demonstrated to contribute to long-term knee health. This has been a successful intervention in patients with isolated tears and tears associated with anterior cruciate ligament (ACL) reconstruction. However, the results of meniscal repair in the setting of revision ACL reconstruction have not been documented. Purpose: To examine the prevalence and 2-year operative success rate of meniscal repairs in the revision ACL setting. Study Design: Case-control study; Level of evidence, 3. Methods: All cases of revision ACL reconstruction with concomitant meniscal repair from a multicenter group between 2006 and 2011 were selected. Two-year follow-up was obtained by phone and email to determine whether any subsequent surgery had occurred to either knee since the initial revision ACL reconstruction. If so, operative reports were obtained, whenever possible, to verify the pathologic condition and subsequent treatment. Results: In total, 218 patients (18%) from 1205 revision ACL reconstructions underwent concurrent meniscal repairs. There were 235 repairs performed: 153 medial, 48 lateral, and 17 medial and lateral. The majority of these repairs (n = 178; 76%) were performed with all-inside techniques. Two-year surgical follow-up was obtained on 90% (197/218) of the cohort. Overall, the meniscal repair failure rate was 8.6% (17/197) at 2 years. Of the 17 failures, 15 were medial (13 all-inside, 2 inside-out) and 2 were lateral (both all-inside). Four medial failures were treated in conjunction with a subsequent repeat revision ACL reconstruction. Conclusion: Meniscal repair in the revision ACL reconstruction setting does not have a high failure rate at 2-year follow-up. Failure rates for medial and lateral repairs were both

Objective: Genome sequencing (GS) is promising for unsolved leukodystrophies, but its efficacy has not been prospectively studied. Methods: A prospective time-delayed crossover design trial of GS to assess the efficacy of GS as a first-line diagnostic tool for genetic white matter disorders took place between December 1, 2015 and September 27, 2017. Patients were randomized to receive GS immediately with concurrent standard of care (SoC) testing, or to receive SoC testing for 4 months followed by GS. Results: Thirty-four individuals were assessed at interim review. The genetic origin of 2 patient's leukoencephalopathy was resolved before randomization. Nine patients were stratified to the immediate intervention group and 23 patients to the delayed-GS arm. The efficacy of GS was significant relative to SoC in the immediate (5/9 [56%] vs 0/9 [0%]; Wild–Seber, p < 0.005) and delayed (control) arms (14/23 [61%] vs 5/23 [22%]; Wild–Seber, p < 0.005). The time to diagnosis was significantly shorter in the immediate-GS group (log-rank test, p = 0.04). The overall diagnostic efficacy of combined GS and SoC approaches was 26 of 34 (76.5%, 95% confidence interval = 58.8–89.3%) in

Objective The study sought to evaluate a novel electronic health record (EHR) add-on application for chronic disease management that uses an integrated display to decrease user cognitive load, improve efficiency, and support clinical decision making. Materials and Methods We designed a chronic disease management application using the technology framework known as SMART on FHIR (Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources). We used mixed methods to obtain user feedback on a prototype to support ambulatory providers managing chronic obstructive pulmonary disease. Each participant managed 2 patient scenarios using the regular EHR with and without access to our prototype in block-randomized order. The primary outcome was the percentage of expert-recommended ideal care tasks completed. Timing, keyboard and mouse use, and participant surveys were also collected. User experiences were captured using a retrospective think-aloud interview analyzed by concept coding. Results With our prototype, the 13 participants completed more recommended care (81% vs 48%; P Discussion Participants completed more recommended care by taking more time when using our prototype. Interviews identified a tension between using the inefficient but familiar EHR vs learning to use our novel prototype. Concept coding of user feedback generated actionable insights. Conclusions Mixed methods can support the design and evaluation of SMART on FHIR EHR add-on applications by enhancing understanding of the user experience.

Background: Lamivudine is a nucleoside reverse transcriptase inhibitor used to treat HIV and hepatitis B. It is primarily cleared by the kidney with renal secretion mediated by OCT2 and MATE. Objective: To use PBPK modeling to assess the impact of renal impairment on lamivudine pharmacokinetics using the Simcyp® Simulator. Methods: The model incorporated the Simcyp® Mechanistic Kidney Model option to predict renal disposition. The model was initially verified using the Simcyp® Healthy Volunteer population. Two discrete patient populations were then created for moderate (GFR 10-40 mL/min) and severe (GFR < 10 mL/min) renal failure (RF), and model simulations were compared to published data. The developed model was then utilized in a clinical study evaluating the clinical experience and plasma exposure of lamivudine when administered at higher than recommended doses to HIV-infected patients with varying degrees of renal impairment. Results: Predicted systemic exposure metrics (Cmax, AUC) compared favorably to published clinical data for each population, with the following fold errors (FE, ratio of predicted and observed data) for Cmax/AUC: Healthy Volunteers 1.04/1.04, Moderate RF 1.03/0.78, Severe RF 0.89/0.79. The model captured lamivudine plasma concentrations measured pre- and post-dose (0.5-1.5hr) in study participants (n = 34). Model simulations demonstrated comparable systemic profiles across patient cohorts, supporting the proposed dosage adjustment scheme. Conclusion: This study illustrates how PBPK modeling can help verify dosing guidelines for patients with varying levels of renal impairment. This approach may also be useful for predicting potential changes in exposure during renal insufficiency for compounds undergoing clinical development.

Background and Objectives: In 2014, family medicine residency programs began to integrate point-of-care ultrasound (POCUS) into training, although very few had an established POCUS curriculum. This study aimed to evaluate the resources, barriers, and scope of POCUS training in family medicine residencies 5 years after its inception. Methods: Questions regarding current training and use of POCUS were included in the 2019 Council of Academic Family Medicine Educational Research Alliance (CERA) survey of family medicine residency program directors, and results compared to similar questions on the 2014 CERA survey. Results: POCUS is becoming a core component of family medicine training programs, with 53% of program directors reporting establishing or an established core curriculum. Only 11% of program directors have no current plans to add POCUS training to their program, compared to 41% in 2014. Despite this increase in training, the reported clinical use of POCUS remains uncommon. Only 27% of programs use six of the eight surveyed POCUS modalities more than once per year. The top three barriers to including POCUS in residency training in 2019 have not changed since 2014, and are (1) a lack of trained faculty, (2) limited access to equipment, and (3) discomfort with interpreting images without radiologist review. Conclusions: Training in POCUS has increased in family medicine residencies over the last 5 years, although practical use of this technology in the clinical setting may be lagging behind. Further research should explore how POCUS can improve outcomes and reduce costs in the primary care setting to better inform training for this technology.

Objectives: To examine metabolic monitoring rates in commercially insured children and adolescents treated with a second-generation antipsychotic (SGA) during calendar years (CYs) 2016 and 2017. Methods: In this retrospective study, data were collected from a large national commercial health plan for the period covering January 1, 2016 to December 31, 2017. Commercially insured children and adolescents, aged 8-19 years with ≥2 SGA prescription claims during the CY, were identified for the CY2016 and CY2017 cohorts. The primary outcome of interest was the percentage of subjects with any glucose or lipid metabolism parameter monitoring. Other calculated metabolic testing rates included glucose, hemoglobin A1c (HbA1c), low-density lipoprotein cholesterol (LDL-C), other cholesterol (including triglycerides), and combined glucose and lipid metabolism testing (≥1 test for blood glucose or HbA1c and ≥1 test for LDL-C or other cholesterol). Results: In CY2016 and CY2017, 1502 and 1239 subjects, respectively, were identified for this study. The most common psychiatric diagnoses in CY2016 and CY2017 were major depressive disorder (57.1%, 56.5%, respectively), anxiety disorders (42.9%, 47.5%), attention-deficit/hyperactivity disorder (41.6%, 45.8%), and bipolar disorder (24.1%, 25.9%). The rate of any metabolic testing was 53.5% in CY2016 and 51.3% in CY2017. Glucose testing (50.3%, 46.9%, respectively) was most common in both CYs, followed by LDL-C testing (31.2%, 28.5%). Rates of combined glucose and lipid metabolism testing were 30.7% in CY2016 and 26.9% in CY2017. Conclusions: Given the known potential for adverse cardiometabolic effects, rates of metabolic monitoring associated with SGA use in children and adolescents urgently need to be improved. There is a critical need for understanding barriers to routine monitoring, particularly of lipids, and developing interventions to enhance metabolic monitoring.

BACKGROUND & AIMS: Esophageal hypervigilance and anxiety are emerging as important drivers of dysphagia symptoms and reduced quality of life across esophageal diagnoses. The esophageal hypervigilance and anxiety scale (EHAS) is a validated measure of these cognitive-affective processes. However, its length may preclude it from use in clinical practice. We aimed to create a short form version of the EHAS using established psychometric practices. METHODS: A retrospective review of a registry of patients who visited a university-based esophageal motility clinic for diagnostic testing was conducted. Patients were included if they completed the 15-item EHAS and questionnaires assessing dysphagia severity and health-related quality of life (HRQOL) at the time of motility testing. Principle components factor analysis identified items for possible removal. Tests for reliability and concurrent validity were performed on the full EHAS and short-form version (EHAS-7). RESULTS: 3,976 adult patients with confirmed esophageal disease were included: 30% with achalasia or EGJOO, 13% with EoE, 13% with GERD, 39% normal motility. Eight items were removed from the scale based on a factor loading of > 0.70, resulting in a single scale 7-item EHAS-7 scored from 0 to 28. The EHAS-7 demonstrated excellent internal consistency (α = 0.91) and split-half reliability (0.88) as was found in the full EHAS in the current study and prior validation. Concurrent validity existed between the EHAS-7 and measures of dysphagia (r = 0.33) and HRQOL (r = -0.73, both P < .001). CONCLUSIONS: The EHAS-7 is a 7-item scale to assess esophageal hypervigilance and symptom-specific anxiety that performs as well as the original 15-item version. Shorter questionnaires allow for implementation in clinical practice. The EHAS-7 is a useful tool for clinicians to quickly assess how hypervigilance and anxiety may be contributing to their patients' clinical presentations. ispartof: CLINICAL GASTROENTEROLOGY AND HEPATOLOGY vol:20 issue:2 pages:E64-E73 ispartof: location:United States status: published

IntroductionIntimate partner violence detrimentally affects the social and emotional well-being of children and mothers. These two populations are impacted both individually and within the context of their relationship with one another. Child mental health, maternal mental health and the mother–child relationship may be impaired as a consequence. Early intervention to prevent or arrest impaired mother–child attachment and child development is needed. Dyadic or relational mental health interventions that include mothers with their children, such as child–parent psychotherapy, are effective in improving the mental health of both children and mothers and also strengthening their relationship. While child–parent psychotherapy has been trialled overseas in several populations, Australian research on relational interventions for children and women recovering from violence is limited. This study aims to assess the acceptability and feasibility of implementing child–parent psychotherapy in Australian families.Methods and analysisUsing a mixed methods, prepost design this feasibility study will examine the acceptability of the intervention to women with preschool aged children (3–5 years, n=15 dyads) and providers, and identify process issues including recruitment, retention and barriers to implementation and sustainability. In addition, intervention efficacy will be assessed using maternal and child health outcomes and functioning, and mother–child attachment measures. Young children’s mental health needs are underserviced in Australia. More research is needed to fully understand parenting in the context of intimate partner violence and what works to help women and children recover. If the intervention is found to be feasible, findings will inform future trials and expansion of child–parent psychotherapy in Australia.Ethics and disseminationEthics approval obtained from clinical sites and the La Trobe University Human Research Ethics Committee (ID: HEC17-108). Results will be disseminated through conference proceedings and academic publications.

Purpose: Recent reports of individuals with cytoplasmic transfer RNA (tRNA) synthetase-related disorders have identified cases with phenotypic variability from the index presentations. We sought to assess phenotypic variability in individuals with AARS1-related disease. Methods: A cross-sectional survey was performed on individuals with biallelic variants in AARS1. Clinical data, neuroimaging, and genetic testing results were reviewed. Alanyl tRNA synthetase (AlaRS) activity was measured in available fibroblasts. Results: We identified 11 affected individuals. Two phenotypic presentations emerged, one with early infantile–onset disease resembling the index cases of AARS1-related epileptic encephalopathy with deficient myelination (n = 7). The second (n = 4) was a later-onset disorder, where disease onset occurred after the first year of life and was characterized on neuroimaging by a progressive posterior predominant leukoencephalopathy evolving to include the frontal white matter. AlaRS activity was significantly reduced in five affected individuals with both early infantile–onset and late-onset phenotypes. Conclusion: We suggest that variants in AARS1 result in a broader clinical spectrum than previously appreciated. The predominant form results in early infantile–onset disease with epileptic encephalopathy and deficient myelination. However, a subgroup of affected individuals manifests with late-onset disease and similarly rapid progressive clinical decline. Longitudinal imaging and clinical follow-up will be valuable in understanding factors affecting disease progression and outcome.

OpenMP is traditionally focused on boosting performance in HPC systems. However, other domains are showing an increasing interest in the use of OpenMP by virtue of key aspects introduced in recent versions of the specification: the tasking model, the accelerator model, and other features like the requires and the assumes directives, which allow defining certain contracts. One example is the safety-critical embedded domain, where several efforts have been initiated towards the adoption of OpenMP. However, the OpenMP specification states that "application developers are responsible for correctly using the OpenMP API to produce a conforming program", being not acceptable in high integrity systems, where aspects such as reliability and resiliency have to be ensured at different levels of criticality. In this scope, programming languages like Ada propose a different paradigm by exposing fewer features to the user, and leaving the responsibility of safely exploiting the full underlying architecture to the compiler and the runtime systems, instead. The philosophy behind this kind of model is to move the responsibility of producing correct parallel programs from users to vendors. In this panel, actors from different domains involved in the use of parallel programming models for the development of high-integrity systems share their thoughts about this topic. This work has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 871669. We would also like to express our gratitude to the organizers of the HILT workshop.

We characterized US pediatric patients with clinical indicators of genetic diseases, focusing on the burden of disease, utilization of genetic testing, and cost of care. Curated lists of diagnosis, procedure, and billing codes were used to identify patients with clinical indicators of genetic disease in healthcare claims from Optum’s de-identified Clinformatics® Database (13,076,038 unique patients). Distinct cohorts were defined to represent permissive and conservative estimates of the number of patients. Clinical phenotypes suggestive of genetic diseases were observed in up to 9.4% of pediatric patients and up to 44.7% of critically-ill infants. Compared with controls, patients with indicators of genetic diseases had higher utilization of services (e.g., mean NICU length of stay of 31.6d in a cohort defined by multiple congenital anomalies or neurological presentations compared with 10.1d for patients in the control population (P

The need to evacuate an ICU or operating theatre complex during a fire or other emergency is a rare event but one potentially fraught with difficulty: Not only is there a risk that patients may come to harm but also that staff may be injured and unable to work. Designing newly-built or refurbished ICUs and operating theatre suites is an opportunity to incorporate mandatory fire safety features and improve the management and outcomes of such emergencies: These include well-marked manual fire call points and oxygen shut off valves (area valve service units); the ability to isolate individual zones; multiple clear exit routes; small bays or side rooms; preference for ground floor ICU location and interconnecting routes with operating theatres; separate clinical and non-clinical areas. ICUs and operating theatre suites should have a bespoke emergency evacuation plan and route map that is readily available. Staff should receive practical fire and evacuation training in their clinical area of work on induction and annually as part of mandatory training, including 'walk-through practice' or simulation training and location of manual fire call points and fire extinguishers, evacuation routes and location and operation of area valve service units. The staff member in charge of each shift should be able to select and operate fire extinguishers and lead an evacuation. Following an emergency evacuation, a network-wide response should be activated, including retrieval and transport of patients to other ICUs if needed. A full investigation should take place and ongoing support and follow-up of staff provided.